[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preeclampsia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preeclampsia":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,93,0,25,[9,59,89,113,145,174,197,225,247,273,302,326,348,367,393,435,458,485,514,537,559,583,607,645,672],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100652879","community-health-worker-support-to-lower-blood-pressure-after-a-pregnancy-with-high-blood-pressure-100652879",false,"NCT07778966","Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure","Alabama Womb to Heart Solution: A Community-Based Cardiovascular Health Intervention After Hypertension in Pregnancy","AW2H","Inclusion Criteria:\n\n* Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count \\[HELLP\\] syndrome) or stage 2 hypertension per American College of Cardiology\u002FAmerican Heart Association (ACC\u002FAHA) guidelines (systolic blood pressure \\[SBP\\] \\>=140 mmHg or diastolic blood pressure \\[DBP\\] \\>=90 mmHg) on two separate occasions at delivery-related hospital discharge or during the postpartum period\n* Delivered in the last six weeks at \\>=14 weeks gestational age, including pregnancy loss\n* 16-56 years old\n* Speaks and writes in English\n* Delivering at University of Alabama at Birmingham (UAB) Hospital\n\nExclusion Criteria:\n\n* Declines randomization\n* Does not speak English\n* Currently incarcerated\n* Currently enrolled in other community health worker studies or services","FEMALE","16 Years","56 Years",{"count":22,"type":23},174,"ESTIMATED","INTERVENTIONAL",[26],"NA","High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or Hemolysis, Elevated Liver enzymes, and Low Platelet (HELLP) syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care.\n\nA total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8 (LE8), help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support.\n\nThe main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video\u002Fphone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.",[29,30,31,32,33,34,35],"Pregnancy-Associated Hypertension","Gestational Hypertension","Preeclampsia","Eclampsia","HELLP Syndrome","Postpartum Hypertension","Stage 2 Hypertension",[37,38,39,40,41,42,43,44,45],"Community health worker","Postpartum","Blood pressure","Self-measured blood pressure monitoring","Cardiovascular disease prevention","Life's Essential 8","Hypertensive disorders of pregnancy","Alabama","Primary care linkage","NOT_YET_RECRUITING","2026-08-20",{"date":49,"type":50},"2026-08-24","ACTUAL",{"date":52,"type":23},"2026-08-31",{"date":54,"type":23},"2030-07-30",{"name":56,"class":57},"University of Alabama at Birmingham","OTHER",1,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":24,"phases":70,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":58},"100652896","phase-4-comparison-of-high--versus-low-dose-aspirin-for-pregnancy-outcomes-in-women-at-high-risk-of-preeclampsia-100652896","NCT07779057","Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia","High Versus Low Dose Aspirin Effects on Fetomaternal Outcomes in Women With High Risk of Preeclampsia","Inclusion Criteria:\n\n* Gestational age 11-14 weeks\n* High risk of preeclampsia\n\nExclusion Criteria:\n\n* Active gastritis\n* Abnormal coagulation profile (INR \\> 1.5)\n* Renal disease\n* Platelet count \\\u003C 150,000\u002Fmm\\^3\n* Fetal malformations\n* Vaginal bleeding","18 Years","45 Years",{"count":69,"type":23},60,[71],"PHASE4","The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia.\n\nThe main question the study aims to answer is:\n\n1. Does taking 150 mg of aspirin reduce the occurrence of preeclampsia more effectively than taking 75 mg of aspirin in pregnant women at high risk of preeclampsia?\n2. Are there differences in stillbirth and newborn birth weight between the two aspirin doses?\n\nThe study will include 224 pregnant women aged 18-45 years who are between 11 and 14 weeks of pregnancy and are identified as being at high risk for preeclampsia. Participants will be randomly assigned to one of two groups.\n\n* Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime.\n* Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime.\n\nParticipants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery.\n\nThe study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth.\n\nThe study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.",[31],[75,76,77,31,78],"Aspirin","Birth weight","Pregnancy","Stillbirth","RECRUITING","2026-08-18",{"date":82,"type":50},"2026-08-21",{"date":84,"type":50},"2026-05-12",{"date":86,"type":23},"2026-11-11",{"name":88,"class":57},"Medicare Hospital (Pvt) Limited",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":24,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":58},"100627435","phase-4-progesterone-preeclampsia-100627435","NCT07448597","Progesterone Preeclampsia","Progesterone Supplementation for the Prevention of Preeclampsia","Inclusion Criteria:\n\n* Pregnant individuals receiving prenatal care at participating clinics\n* \\\u003C12 weeks gestation with a viable intrauterine pregnancy\n* Age ≥18 years\n* English-speaking\n\nExclusion Criteria:\n\n* Unable or unwilling to self-administer vaginal progesterone\n* Inability or unwillingness to provide informed consent",true,{"count":98,"type":23},642,[71],"This randomized controlled trial evaluates whether nightly vaginal micronized progesterone (400 mg) initiated before 12 weeks' gestation reduces the incidence of preeclampsia in low-risk pregnant individuals. Participants will be randomly assigned (1:1) to receive either vaginal progesterone through 16 weeks' gestation or routine prenatal care without progesterone. Maternal and neonatal outcomes-including development of preeclampsia, obstetric complications, gestational diabetes, preterm birth, and neonatal morbidity-will be collected via chart review. The study aims to determine whether early progesterone supplementation decreases the risk of preeclampsia.",[31,102],"Hypertensive Disorder of Pregnancy",[104],"Progesterone","2026-08-13",{"date":107,"type":50},"2026-08-17",{"date":105,"type":50},{"date":110,"type":23},"2028-08-01",{"name":112,"class":57},"Medical University of South Carolina",{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":24,"phases":123,"briefSummary":124,"conditions":125,"keywords":131,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100608263","the-preeclampsia-postpartum-prevention-trial-100608263","NCT07199283","The PreEclampsia Postpartum Prevention Trial","The PEPP Trial: A Postpartum Bundle Intervention to Improve Cardiometabolic Health in Women After a First Pregnancy Affected by Preeclampsia - a Multi-centre Randomised Controlled Trial","PEPP","Inclusion Criteria\n\n* First-time mothers postpartum\n* Preeclampsia during first pregnancy\n* Age ≥ 18 years\n* Singleton live birth (infant still alive)\n* Ability to understand and speak Swedish, English\n* Having a smartphone (Android or iOS)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pre-pregnancy hypertension\n* Diabetes mellitus type I or II\n* Cardiovascular disease\n* Kidney disease\n* Systemic lupus erythematosus\n* Antiphospholipid syndrome\n* Previous or current eating disorders\n* Ongoing new pregnancy",{"count":122,"type":23},356,[26],"The goal of this clinical trial is to learn if a postpartum bundle intervention can improve cardiometabolic health and lifestyle-related factors in women who have had preeclampsia during their first pregnancy. The main questions it aims to answer are:\n\n* Does the 9-month intervention reduce systolic and diastolic blood pressure?\n* Does the intervention promote postpartum weight loss?\n* Does the intervention affect weight and blood pressure depending on early pregnancy BMI? Researchers will compare the bundle intervention to standard care to see if the intervention improves cardiometabolic health and lifestyle outcomes.\n\nAll participants will attend clinical visits for outcome assessments.\n\nParticipants in the intervention group will:\n\n* Receive online targeted screening and group meetings with study personnel\n* Use the trial-specific PEPP app to access self-monitoring tools for blood pressure and weight, lifestyle modification, and health education\n* Follow the intervention in two phases: starting after inclusion (≈8 weeks postpartum) with a Light phase (baseline-3 months) and progressing to an Intensive phase (3-9 months)",[31,126,127,128,129,130],"Postpartum Period","Hypertension","Cardiovascular Diseases","Overweight","Obesity",[31,132,133,127,134],"Postpartum prevention","Prevention cardiometabolic disease","Postpartum weight loss","2026-08-11",{"date":137,"type":50},"2026-08-12",{"date":139,"type":50},"2026-04-20",{"date":141,"type":23},"2028-04",{"name":143,"class":57},"Karolinska Institutet",2,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":155,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100518637","phase-3-pi4---a-trial-assessing-metformin-to-prolong-gestation-in-preterm-preeclampsia-100518637","NCT06033131","PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia","Preeclampsia Intervention 4 - A Triple Blind Phase III Randomised Controlled Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia","PI4","Inclusion Criteria:\n\n* A diagnosis of preeclampsia (defined as hypertension in combination with significant proteinuria (albumin\u002Fcreatinine ratio \\>8 mg\u002Fmmol, protein\u002Fcreatinine ratio\\>30 mg\u002Fmmol or \\>2+ protein on a urinary dipstick) has been made by the attending clinician\n* The managing clinicians have made the assessment to proceed with expectant management.\n* The subject has given written consent to participate in the study.\n* The woman must be 18 years of age or older\n* The gestational age is between 22+0 weeks to 33+6 weeks with a viable fetus\n* The woman carries a singleton pregnancy\n\nExclusion Criteria:\n\n* Contraindications to treatment with metformin as outlined in SmPC\n* Contraindications for expectant management of preeclampsia such as an immediate indication for delivery according to SFOG guidelines for preeclampsia (https:\u002F\u002Fwww.sfog.se\u002Fmedia\u002F338533\u002Fpe-riktlinje-230214.pdf).\n* Type 1 Diabetes Mellitus\n* Current use of metformin\n* Known or suspected allergies against metformin\n* Reluctance or language difficulties that result in difficulty understanding the meaning of study participation\n* Unable to understand the informed consent process\n* Previous participation in the study\n* Established fetal compromise that necessitates imminent delivery (including planned delivery after 48 hours of corticosteroid treatment). This will be decided by the clinical team before expectant management is offered to the patient.\n* Suspicion of a major known fetal anomaly or malformation.\n* Renal disease or dysfunction, suggested by a creatinine level greater than or equal to 125 µmol\u002FL or rapidly declining renal function\n* Known acute or chronic metabolic acidosis, including diabetic ketoacidosis\n* Not suitable for inclusion by the opinion of the investigator",{"count":154,"type":23},294,[156],"PHASE3","Preterm preeclampsia is a severe condition for both the mother and the fetus. Currently, the only treatment available to stop disease progression is termination\u002Fdelivery of the fetus and placenta. Therefore, preterm preeclampsia carries the highest rates of neonatal morbidity and mortality due to iatrogenic preterm birth. There is evidence suggesting metformin, a drug commonly used to treat diabetes in and outside pregnancy, may be able to counter the pathophysiology of preeclampsia, raising the possibility that it could be used to treat the condition. This multi centre double blind randomised controlled trial aims to investigate if metformin can prolong gestation, lower neonatal length of stay and increase birthweight in a Nordic setting.",[31],[31,160,161,162,76,163],"Metformin","Preterm birth","Prolongation","Length of stay in neonatal care","2026-08-04",{"date":166,"type":50},"2026-08-07",{"date":168,"type":50},"2024-01-19",{"date":170,"type":23},"2029-12-31",{"name":172,"class":57},"Lina Bergman",17,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":24,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":58},"100610074","phase-3-cardiovascular-protection-after-preeclampsia-with-enalapril-100610074","NCT07222852","Cardiovascular Protection After Preeclampsia With Enalapril","CAPP-E","Inclusion Criteria:\n\n* Postpartum individuals\n* ≥18 years old\n* Hypertensive disorder of pregnancy\n* Enrolled in Women and Infants Hospital Hypertension Equity remote monitoring program.\n\nExclusion Criteria:\n\n* Maternal cardiac disease\n* Individuals with pre-pregnancy hypertension or diabetes\n* Allergy or contraindication to enalapril",{"count":69,"type":23},[156],"The purpose of this study is to learn if postpartum women are willing to be randomized to different blood pressure medicines after delivery and how that affects blood pressure in women with hypertensive disorders of pregnancy.",[31,102,127,30,185],"Gestational Hypertension After Childbirth",[187],"postpartum hypertension, preeclampsia, gestational hypertension","2026-08-03",{"date":190,"type":50},"2026-08-06",{"date":192,"type":50},"2026-01-01",{"date":194,"type":23},"2027-10-15",{"name":196,"class":57},"Women and Infants Hospital of Rhode Island",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":204,"targetDuration":206,"studyType":207,"phases":4,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":58},"100650176","role-of-progesterone-membrane-receptors-in-the-pathogenesis-of-preeclampsia-100650176","NCT07745036","Role of Progesterone Membrane Receptors in the Pathogenesis of Preeclampsia","Investigation of Progesterone Membrane Receptor Expression in Placental Tissue of Women With Preeclampsia and Their Potential Role in the Pathogenesis of Preeclampsia","Inclusion Criteria:\n\nPreeclampsia Group Women aged 18-45 years Singleton pregnancy Diagnosis of preeclampsia according to ACOG criteria Delivery at the study center Written informed consent Control Group Women aged 18-45 years Singleton pregnancy Normotensive healthy pregnancy Delivery at the study center Written informed consent\n\nExclusion Criteria:\n\nAge \\\u003C18 or \\>45 years Multiple gestation Fetal structural or chromosomal anomalies Chronic hypertension Pre-existing diabetes mellitus Autoimmune diseases Renal disease Other major systemic disorders\n\n\\-",{"count":205,"type":23},90,"1 Day","OBSERVATIONAL","Preeclampsia is a pregnancy-specific hypertensive disorder and remains a leading cause of maternal and perinatal morbidity and mortality worldwide. Although abnormal placentation, impaired trophoblast invasion, endothelial dysfunction, and immune dysregulation have been implicated in its pathogenesis, the underlying molecular mechanisms are not fully understood.\n\nProgesterone plays a critical role in the maintenance of pregnancy through both classical nuclear receptors and membrane-associated progesterone receptors. Emerging evidence suggests that progesterone membrane receptors, including progesterone receptor membrane component 1 (PGRMC1), progesterone receptor membrane component 2 (PGRMC2), and members of the progestin and adipoQ receptor (PAQR) family, may regulate trophoblast invasion, placental development, and inflammatory responses.\n\nThis study aims to compare the placental expression levels of PGRMC1, PGRMC2, and PAQR family receptors between women with preeclampsia and healthy pregnant controls and to investigate their potential role in the pathophysiology of preeclampsia.",[31,210],"Preeclampsia Complications",[212,213,214,215,216,77],"Progesterone Membrane Receptor","PGRMC1","PGRMC2","PAQR","Placenta","2026-07-29",{"date":164,"type":50},{"date":220,"type":50},"2025-09-01",{"date":222,"type":23},"2027-01-15",{"name":224,"class":57},"Samsun University",{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":58},"100647966","early-phase-1-antidepressant-therapy-for-improved-blood-vessel-health-after-preeclampsia-100647966","NCT07715669","Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia","Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia","Inclusion Criteria:\n\n* 18-24 years old,\n* 12 weeks - 5 years post pregnancy\n* one of the following:\n* history of a normal pregnancy with a current diagnosis of depression,\n* history of a normal pregnancy without a current diagnosis of depression,\n* history of a preeclamptic pregnancy with a current diagnosis of depression\n* history of preeclamptic pregnancy without a current diagnosis of depression.\n\nExclusion Criteria:\n\n* history of cardiovascular, metabolic, and\u002For skin diseases\n* current or history of tobacco\u002Fnicotine\u002F e-cigarette use\n* history of gestational diabetes\n* current antihypertensive or cholesterol-lowering medication\n* currently pregnant\n* allergy to materials used during the experiment (e.g. latex),\n* known allergy to study drugs\n* currently using SSRI medications",{"count":233,"type":23},40,[235],"EARLY_PHASE1","Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia.",[31,238],"Endothelial Function","2026-07-27",{"date":217,"type":50},{"date":242,"type":23},"2026-08-30",{"date":244,"type":23},"2027-06",{"name":246,"class":57},"Anna Stanhewicz, PhD",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":256,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":58},"100643173","mobile-health-program-for-post-preeclampsia-hypertension-100643173","NCT07599579","Mobile Health Program for Post-Preeclampsia Hypertension","Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy","Inclusion Criteria:\n\n* Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.\n* Evidence of current stage 2 HTN (BP ≥ 140\u002F90 mmHg with or without treatment with antihypertensive medication).\n\nExclusion Criteria:\n\n* Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).\n* Males will also be excluded from this study as it focuses on pregnancy related conditions.\n* Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.",{"count":255,"type":23},50,[26],"Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.",[259,31,260],"Hypertension (HTN)","Hypertensive Disorders of Pregnancy (HDP)",[262,263,264,265],"hypertension","preeclampsia","coaching","home blood pressure monitoring",{"date":217,"type":50},{"date":268,"type":50},"2026-07-22",{"date":270,"type":23},"2027-10",{"name":272,"class":57},"University of Pittsburgh",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":58},"100648961","endothelial-extracellular-vesicles-as-biomarkers-of-endothelial-activation-in-pregnant-women-with-hypertensive-disorders-of-pregnancy-100648961","NCT07728656","Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy","Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy","HYPER-endoEV-p","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years.\n* Singleton pregnancy.\n* Ability to provide written informed consent.\n* Normotensive pregnancy or diagnosis of gestational hypertension or preeclampsia according to current clinical guidelines.\n* Ability to comply with study procedures.\n\nExclusion Criteria:\n\n* Chronic hypertension diagnosed before pregnancy.\n* Multiple pregnancy.\n* Pre-existing diabetes mellitus.\n* Chronic kidney disease.\n* Autoimmune disease.\n* Known cardiovascular disease.\n* Active infection or inflammatory disease.\n* Malignancy.\n* Inability or unwillingness to provide informed consent.",{"count":282,"type":23},80,"Hypertensive disorders of pregnancy are associated with endothelial dysfunction and increased maternal and fetal morbidity. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their relationship with blood pressure and endothelial function during pregnancy remains incompletely understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive pregnant women and pregnant women with hypertensive disorders of pregnancy. The study will also investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and circulating biomarkers of endothelial activation. The findings may improve understanding of endothelial injury during pregnancy and support the development of non-invasive biomarkers for early detection and monitoring of hypertensive disorders of pregnancy.",[102,30,31],[286,30,31,77,287,288,289,290,291,292,293,294],"Hypertensive Disorders of Pregnancy","Endothelial Dysfunction","Endothelial Extracellular Vesicles","Extracellular Vesicles","Endothelial Activation","Biomarkers","Microvascular Function","Laser Doppler Flowmetry","Cardiovascular Risk",{"date":239,"type":50},{"date":297,"type":50},"2026-04-01",{"date":299,"type":23},"2029-09-30",{"name":301,"class":57},"Josip Juraj Strossmayer University of Osijek",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":144},"100609719","mindfulness-and-wearable-biosensors-to-prevent-hypertensive-disorders-of-pregnancy-100609719","NCT07218237","Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy","Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP","MINDBP","Inclusion Criteria:\n\n* Pregnant patients at gestational age \\\u003C= 16 weeks\n* Live, non-anomalous gestation\n* Normotensive at enrollment\n* Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG\u002FUSPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy\n\nExclusion Criteria:\n\n* Multiple gestation\n* Chronic (pregestational hypertension)\n* Inability of unwillingness to provide informed consent\n* Active suicidality or psychosis\n* Ongoing mind-body practice (e.g., yoga, meditation, mindfulness \\>= once per week)",{"count":205,"type":23},[26],"The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. The primary outcome is study feasibility.",[31],[43,315,316],"Mindfulness","Biofeedback","2026-07-16",{"date":319,"type":50},"2026-07-20",{"date":321,"type":50},"2026-04-28",{"date":323,"type":23},"2028-10",{"name":325,"class":57},"Medical College of Wisconsin",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":334,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":4},"100645508","identification-of-genes-of-interest-for-severe-forms-of-preeclampsia-100645508","NCT07703826","Identification of Genes of Interest for Severe Forms of Preeclampsia","Identification of Genes of Interest for Severe Forms of Preeclampsia in a Cohort of Pregnant Women With a Precise Phenotype","PRE-OMIQUES","Inclusion Criteria:\n\nInclusion criteria for patients in the experimental group P:\n\n\\- Pregnant women between 18 and 45 years old, between 24 and 41 weeks of amenorrhea (WA), with severe preeclampsia defined according to the criteria of the joint expert recommendations of the French National College of Gynecologists and Obstetricians (CNGOF) and the French Society of Anesthesia and Intensive Care (SFAR) from 2020 \"Management of the patient with severe preeclampsia.\" These criteria are: gestational hypertension with systolic ≥ 140 mmHg and\u002For diastolic ≥ 90 mmHg, and proteinuria ≥ 0.3g\u002F24h, plus at least one of the following severity criteria:\n\n* Severe hypertension (SBP ≥ 160 mmHg and\u002For DBP ≥ 110 mmHg) or uncontrolled.\n* Proteinuria \\> 3g\u002F24h.\n* Creatinine ≥ 90 μmol\u002FL.\n* Oliguria ≤ 500 mL\u002F24h or ≤ 25 mL\u002Fh.\n* Thrombocytopenia \\\u003C 100,000\u002Fmm3\n* Liver enzyme elevation with AST\u002FALT \\>2x normal.\n* Epigastric abdominal pain and\u002For persistent or severe right upper quadrant pain \"like a band.\"\n* Chest pain, shortness of breath, acute pulmonary edema.\n* Neurological signs: severe headaches not responding to treatment, persistent visual or auditory disturbances, hyperactive, widespread, and polykinetic tendon reflexes.\n* Patient's free and informed consent regarding the collection of maternal blood and urine.\n* Consent from both legal guardians regarding the collection of cord blood, placenta samples, and newborn data.\n\nInclusion criteria for patients in the control group:\n\n* Pregnant women between 18 and 45 years old and between 24 and 41 weeks of gestation, with a pregnancy without any complications\n* Free and informed consent from the patient regarding the collection of maternal blood and urine\n* Consent from both holders of parental authority regarding the collection of cord blood, placental fragments, and newborn data\n\nExclusion Criteria:\n\nEXCLUSION CRITERIA: for all patients\n\n* Diabetes prior to pregnancy\n* Multiple pregnancy\n* Long-term medication treatment (except usual pregnancy supplements)\n* Smoking, alcohol, or drug use during pregnancy\n* Pre-existing liver, kidney, or heart failure\n* History of bariatric surgery\n* Neonatal acidosis with arterial cord pH below 7.0 (rare event)\n* Genetic or chromosomal abnormality of the mother and\u002For newborn diagnosed prenatally\n* Fetal malformation diagnosed prenatally\n* Refusal to participate in the study\n* Person unable to consent or under protection (guardianship, curatorship)\n* Minor\n* Inability to participate in the entire study\n\nExclusion criteria for patients in the control group T: For women in the control group, any obstetric condition (apart from delivery complications).",{"count":335,"type":23},100,"Preeclampsia is a pregnancy complication characterized by high blood pressure associated with damage to various organs, especially the kidneys. It happens in about 1 to 5% of pregnant women and can cause serious problems for both the mother and the baby.\n\nSeveral multi-omics studies have already been conducted on preeclampsia, with promising results. However, this is preliminary data that requires further studies. The molecular markers identified in this type of study could potentially be used, first of all, for the early screening of this condition, which is not yet reliably achievable. In addition, the knowledge gained from this research would help us better understand the pathophysiology of preeclampsia. Therefore, the investigators' goal is to carry out a multi-omics analysis of preeclampsia to uncover the genetic and molecular mechanisms involved in this condition.",[31,338],"Severe Preeclampsia","2026-07-09",{"date":341,"type":50},"2026-07-14",{"date":343,"type":23},"2026-09-01",{"date":345,"type":23},"2031-01-01",{"name":347,"class":57},"University Hospital, Strasbourg, France",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":355,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":58},"100374351","exosome-cargo-from-preeclampsia-patients-100374351","NCT04154332","Exosome Cargo From Preeclampsia Patients","Exosome Cargo From Preeclamptic Patients Mediates Endothelial Dysfunction, Subsequent Cardiovascular Remodeling, and the Preeclamptic Phenotype","Inclusion\n\n1. Preeclampsia patients: Age ≥ 18 years; Diagnosis of preeclampsia with severe features:\n\n   1. BP ≥160\u002F110 after 20 weeks gestation AND ≥300 mg\u002Fday proteinuria or protein\u002Fcreatinine ratio of 0.3 mg\u002FdL; OR\n   2. BP ≥160\u002F110 after 20 weeks gestation with any of the following co-conditions: platelet count less than 100,000 X 109\u002FL, AST\u002FALT enzymes elevated to twice the upper limit of normal, serum creatinine ≥1.1 mg\u002FdL or a doubling of the creatinine from baseline, pulmonary edema, new-onset headache, and\u002For visual disturbances.\n2. Control patients: Age ≥ 18 years; no diagnosis of preeclampsia or any pregnancy-induced hypertension disorder.\n3. Pre-clampsia patients will be defined as =140 mmHg systolic or =90mmHg diastolic BP with at least at least 2 occasions 4 hours apart after 20 weeks of gestation in previously normotensive women with at least one of the following symptoms: =300 mg\u002Fday proteinuria, protein\u002Fcreatinine ratio of 0.3 mg\u002FdL, platelet count \\\u003C 100,000 X 109\u002FL, elevated liver enzymes, serum creatinine =1.1 mg\u002FdL, pulmonary edema, or new-onset headache or visual disturbances.\n\n   1. \\>22w 0d gestational age -33w 6d GA (n=16)\n   2. \\>= 34 wGA (n=16)\n4. Pre-eclampsia with severe features will be defined as blood pressure =160 mmHg systolic or =110 mmHg diastolic BP at least 2 occasions 4 hours apart after 20 weeks of gestation with any of the additional diagnostic criteria listed above.\n\n   1. \\>22w 0d gestational age -33w 6d GA (n=16)\n   2. \\>= 34 wGA (n=16)\n5. Healthy gestational age matched controls:\n\n   1. \\>22w 0d gestational age -33w 6d GA (n=32)\n   2. \\>= 34 wGA (n=32)\n\nExclusion criteria:\n\n1. Preeclampsia patients: Age \\\u003C 18 years; Any other diagnosis of pregnancy-induced hypertension that isn't preeclampsia with severe features (i.e. gestational hypertension or preeclampsia without severe features).\n2. Control Patients: Age \\\u003C 18 years; Any diagnosis of pregnancy-induced hypertension.",{"count":356,"type":23},64,"Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the pathophysiological changes associated with the systemic disease. By isolating these exosomes from maternal blood and placental tissue in patients diagnosed with preeclampsia and studying their biochemical, cellular and molecular mechanism in an animal model, the investigators hope to elucidate the critical role that exosomal cargo plays in the development of preeclampsia and cardiovascular remodeling. This will be accomplished by obtaining patient samples from volunteers delivering at the Women and Infants Center and taking the samples to the lab for quantification, characterization, and identification of key functional roles through in\u002Fex vivo, in vitro, and profiling studies. The investigators believe this work will be valuable as hope exists to define the functional role exosomes play in the development of preeclampsia that leads to cardiovascular remodeling. Data from this study will shed more light on the functional role of exosomal cargo in normal and pathological pregnancies and point towards novel therapeutic intervention strategies for preeclampsia associated with cardiovascular disease.",[31],"2026-07-02",{"date":361,"type":50},"2026-07-07",{"date":363,"type":50},"2019-12-02",{"date":365,"type":23},"2031-12-15",{"name":56,"class":57},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":4},"100643973","advancing-stillbirth-prevention-through-innovative-risk-evaluation-aspire-clinical-study-100643973","NCT07669935","Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study","A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications","ASPIRE","Inclusion Criteria:\n\n* Age ≥18 years\n* Nulliparous (no previous births ≥20wk GA)\n* Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0\u002F7-17 6\u002F7 weeks of gestation\n* Ability to consent and comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Multiple gestation\n* Inability to provide blood\n* Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual\n* Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)\n* Current or recent (within two months) participation in an interventional clinical study.","99 Years",{"count":377,"type":23},5500,"ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \\[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\\] and risk of adverse outcomes.",[380,381,31,382,383],"GDM","Preterm Preeclampsia","Fetal Growth Restriction (FGR)","Pregnancy Complications","2026-06-25",{"date":386,"type":50},"2026-06-29",{"date":388,"type":23},"2026-07-30",{"date":390,"type":23},"2028-12-01",{"name":392,"class":57},"Medicines360",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":403,"briefSummary":404,"conditions":405,"keywords":424,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":58},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442","NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","PTBCARE+","Inclusion Criteria:\n\n1. Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 2763g 6 lbs 1.5 oz \\> 2379g 5 lbs 3.9 oz 35 weeks \\> 3084g 6 lbs 12.8 oz \\> 2661g 5 lbs 13.9 oz\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC).\n\nExclusion Criteria:\n\n1. Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and\u002For confound the study results.\n\n   o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. If a major congenital anomaly is diagnosed \\*after\\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.\n8. Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.\n\n   * Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.\n   * The term \"suspected aneuploidy\" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.",{"count":402,"type":23},1228,[26],"The goal of this clinical trial is to learn if a personalized prenatal support program \\[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \\& Beyond, (PTBCARE+)\\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\\[s\\] it aims to answer are:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.\n* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.\n\nPeople who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[406,407,408,31,409,286,410,411,412,413,414,77,383,415,416,417,418,419,420,421,422,423],"Preterm Birth Complication","Preterm Birth","Preterm Birth Recurrence","Preeclampsia (PE)","Support Program","Stress","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy Induced Hypertension","Neonates and Preterm Infants","Cervical Insufficiency","Social Determinants of Health (SDOH)","Cervical Shortening","Disparities in Pregnancy Complications","Disparities","Prenatal Care","Care Coordination",[399,425,426,427],"pregnancy-related disparities","patient support program","enhanced prenatal care",{"date":386,"type":50},{"date":430,"type":23},"2026-08-01",{"date":432,"type":23},"2029-01",{"name":434,"class":57},"University of North Carolina, Chapel Hill",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":24,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":58},"100502797","optimizing-cardiovascular-preventive-care-for-women-following-hypertensive-disorders-of-pregnancy-100502797","NCT05826925","Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy","Inclusion Criteria:\n\n* Delivered a pregnancy complicated by a hypertensive disorder of pregnancy at the University of Utah during the current hospital admission\n* Ability to speak and read English or Spanish\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Cardiovascular disease diagnosis (history of peripheral artery disease, stroke, or myocardial infarction)\n* Impairment of cognitive function or vision that prohibits communication and\u002For reading the decision aid.",{"count":442,"type":23},30,[26],"Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.",[446,447,31,128,448],"Hypertension, Pregnancy Induced","Hypertension Complicating Pregnancy","Patient Engagement","2026-06-22",{"date":451,"type":50},"2026-06-23",{"date":453,"type":23},"2026-07-15",{"date":455,"type":23},"2027-08",{"name":457,"class":57},"University of Utah",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":24,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"100644093","phase-3-optimizing-the-use-of-aspirin-for-the-prevention-of-preeclampsia-100644093","NCT07665853","Optimizing the Use of Aspirin for the Prevention of Preeclampsia","Optim-PRE","Inclusion Criteria:\n\n* Age 18 years or older at time of enrollment.\n* Singleton pregnancy.\n* Ability to read and understand the informed consent form.\n* Having undergone first-trimester preeclampsia screening between 11+0 and 13+6 weeks of gestation using a validated multiparametric algorithm (FMF algorithm at a risk cutoff of 1:100, or Gaussian algorithm at a cutoff of 1:170) and being classified as high risk for preterm preeclampsia.\n* Currently taking aspirin 150 mg\u002Fday initiated after first-trimester high-risk classification, in accordance with standard clinical practice.\n* Voluntary signing of the informed consent form and willingness to comply with the study requirements, including acceptance of the assigned aspirin treatment duration, additional blood tests, and additional ultrasound assessments.\n\nExclusion Criteria:\n\n* Early pregnancy loss, intrauterine fetal death, or fetus with major structural malformations diagnosed at the time of enrollment.\n* Fetus affected by a known genetic or chromosomal disease.\n* Contraindication, allergy, or intolerance to aspirin (acetylsalicylic acid).\n* Any medical condition that makes aspirin discontinuation unsafe or impossible (e.g., antiphospholipid syndrome, mechanical heart valve, or other conditions requiring indefinite antiplatelet or anticoagulant therapy).",{"count":466,"type":23},15160,[156],"Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation. High-risk women are identified through a multiparametric first-trimester screening that combines maternal history, blood pressure, uterine artery blood flow, and placental growth factor (PlGF). Although this screening effectively identifies women at risk, the majority of those classified as high risk will not develop PE. As a result, a large proportion of pregnant women receive prolonged aspirin treatment without benefit, while remaining exposed to its potential side effects, including increased bleeding risk.\n\nAspirin prevents PE primarily by improving placental development during the first half of pregnancy. Whether continuing ASA beyond 24-28 weeks provides additional protection remains unclear. A previous randomized trial demonstrated that stopping ASA at 24-28 weeks was non-inferior to continuing until 36 weeks in a predominantly European population. However, whether this finding applies to more diverse populations, including women of African origin who carry a substantially higher baseline risk of PE, has not been established.\n\nThis is a multicenter, randomized, open-label, parallel-group, phase III non-inferiority trial conducted across sites in Europe and Africa. A total of 15,160 pregnant women at high risk for PE from first-trimester screening, currently under ASA treatment, will be randomized in a 1:1 ratio before 28 weeks of gestation to either discontinue ASA at 24-28 weeks or continue ASA until 36 weeks of gestation.",[31],[31,471,472,473,474],"First Trimester Screening","Placental Growth Factor","Ophthalmic Artery Doppler","Acetyl Salicylic Acid (ASA)","2026-06-18",{"date":477,"type":50},"2026-06-24",{"date":479,"type":23},"2026-07-01",{"date":481,"type":23},"2028-05",{"name":483,"class":57},"Hospital Universitari Vall d'Hebron Research Institute",38,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":96,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":494,"briefSummary":495,"conditions":496,"keywords":500,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":512,"locationsCount":58},"100641377","polyphenol-intake-mediterranean-diet-adherence-and-oxidative-stress-in-pregnancy-100641377","NCT07656532","Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy","Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy","PREGPOLY","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older.\n* Singleton pregnancy.\n* Gestational age between 8 and 11 weeks at enrollment.\n* Receiving prenatal care within the Salamanca Health Area.\n* Able to understand the study information and provide written informed consent.\n* No clinical restrictions that would contraindicate dietary modifications.\n\nExclusion Criteria:\n\n* Medical or obstetric conditions that contraindicate dietary modifications.\n* Active metabolic, renal, or hepatic disease.\n* Severe hyperemesis gravidarum or gastrointestinal disorders limiting food intake.\n* Allergy or intolerance to cocoa.\n* Habitual high cocoa or chocolate consumption (\\>30 g\u002Fday).\n* Multiple pregnancy.\n* Severe obstetric complications diagnosed before enrollment.\n* Inability to comply with study procedures, attend follow-up visits, or communication barriers that could interfere with participation.",{"count":69,"type":23},[26],"This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes.\n\nPregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role.\n\nPregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations.\n\nThe intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes.\n\nThe aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.",[77,497,31,498,499,287],"Gestational Diabetes Mellitus (GDM)","Hypertension, Pregnancy-Induced","Oxidative Stress",[501,502,503,504,505,506],"Mediterranean diet","Polyphenols","Cocoa supplementation","Oxidative stress","Endothelial function","Randomized controlled trial","2026-06-14",{"date":475,"type":50},{"date":343,"type":23},{"date":511,"type":23},"2028-10-01",{"name":513,"class":57},"University of Salamanca",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":522,"enrollmentInfo":523,"targetDuration":4,"studyType":24,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":58},"100642709","vitamin-d3-supplementation-regimens-and-preeclampsia-risk-100642709","NCT07648706","Vitamin D3 Supplementation Regimens and Preeclampsia Risk","Effect of Different Dosages of Vitamin D3 Supplementation on the Risk of Preeclampsia in Pregnant Women With Vitamin D Deficiency","VitD-PE-RCT","Inclusion Criteria:\n\n* Singleton pregnancy\n* Pregnant women between 8 and 18 weeks of gestation\n* Serum 25-hydroxyvitamin D \\[25(OH)D\\] level \\\u003C 25 ng\u002FmL\n* Willing and able to provide written informed consent\n* Planning to receive ongoing antenatal care and deliver at Al-Thawra Modern General Hospital.\n\nExclusion Criteria:\n\n* Uncontrolled chronic hypertension\n* Current use of vitamin D supplementation before enrollment\n* Severe chronic kidney disease\n* Pre-existing diabetes mellitus\n* Autoimmune or immunological disorders\n* Known fetal congenital anomalies\n* Primary hyperparathyroidism\n* Thyroid disease\n* Use of medications that affect vitamin D or calcium metabolism\n* Inability or unwillingness to comply with the study protocol or follow-up schedule","40 Years",{"count":524,"type":23},268,[26],"This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen.\n\nIt aims to compara the effect of two different vitamin D3 supplementation regimens during pregnancy on the risk of pre-eclampsia among women with confirmed vitamin D deficiency.\n\nPregnant women attending antenatal care and diagnosed with vitamin D deficiency will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups:one group receiving vitamin D3 50,000 IU every two weeks and the other group receiving vitamin D3 5,000 IU weekly,in addition to standard antenatal care.\n\nThe study will include singleton pregnancies between 8\\_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng \u002FmL . Women with chronic conditions that may affect pregnancy outcomes or vitamin D metabolism will be excluded. Participants will be followed throughout pregnancy to assess the development of pre-eclampsia and other maternal and fetal outcomes.",[31],"2026-06-12",{"date":530,"type":50},"2026-06-15",{"date":532,"type":50},"2024-08-04",{"date":534,"type":23},"2026-09",{"name":536,"class":57},"Sana'a University",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":24,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":4},"100542048","use-of-allied-health-professionals-to-improve-treatment-of-disease-100542048","NCT06337799","Use of Allied-health Professionals to Improve Treatment of Disease","Use of Non-physician Allied-health Professionals to Recruit (and Follow) Research Participants, Sustain Engagement, and Improve and Diagnose Treatment of Diseases by Facilitating Transitions of Care","Inclusion Criteria:\n\n* Biological mothers delivering at UIHC or attending a well-child visit for an infant between 1 month and 9 months\n* Preeclampsia during pregnancy\n* Preceived prenatal care at UIHC\n* Owns a smartphone\n\nExclusion Criteria:\n\n* Arm circumference greater than 17 inches\n* Prisoner status\n* Unable to provide own written informed consent","55 Years",{"count":546,"type":23},200,[26],"The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.\n\nParticipants will:\n\nTake their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months.",[31],"2026-06-02",{"date":552,"type":50},"2026-06-04",{"date":554,"type":23},"2026-10",{"date":556,"type":23},"2030-03",{"name":558,"class":57},"University of Iowa",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":24,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":579,"leadSponsor":581,"locationsCount":58},"100490174","feasibility-of-a-telemonitoring-program-for-pregnant-women-at-high-risk-for-preeclampsia-in-pakistan-100490174","NCT05662696","Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan","Feasibility of Implementing a Mobile Phone-based Telemonitoring Program to Support Pregnant Women at High-risk for Preeclampsia in Karachi, Pakistan","Inclusion Criteria:\n\n* Pregnant women at high-risk for preeclampsia (HRPE) who are either in their first or second trimester of pregnancy. The definition of HRPE will follow that of the NICE guidelines that define pregnant women at HRPE as those who have one high-risk factor or more than one moderate risk factor for preeclampsia.\n* Participants who can speak and read (at least at a rudimentary level with help from a caregiver) the Urdu language for ease of communication with the research team and to be able to use the telemonitoring system.\n* Partners (almost always male husbands in the Pakistani culture) and\u002For other caregivers (e.g., mother and mother-in-law) of pregnant women \\[for post-study interviews\\]\n* Clinicians and nurses involved in the implementation of the telemonitoring program \\[for post-study interviews\\]\n\nExclusion Criteria:\n\n* Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition",{"count":255,"type":23},[26],"High maternal mortality from preeclampsia\u002Feclampsia results from a lack of early identification and management of pregnant women at high risk for preeclampsia. A potential tool to support pregnant women at high risk for preeclampsia is telemonitoring. Most telemonitoring interventions have been implemented in high-income countries and thus there is limited evidence on the use and effectiveness of telemonitoring for pregnant women in low-middle-income countries (LMICs). The scarce evidence on the feasibility of telemonitoring program implementation limits the understanding of the process and mechanisms through which the intervention works in LMICs. The study will explore the feasibility of implementing a mobile phone-based telemonitoring program for pregnant women at high-risk for preeclampsia in Karachi, Pakistan. The study will be conducted at the Jinnah Post Graduate Medical Center in Karachi, Pakistan.\n\nThe study will use a mixed-methods design to recruit 50 pregnant women at high risk for preeclampsia to assess clinical feasibility across the five foci of Bowen's framework including acceptability, demand, implementation, practicality, and limited-efficacy testing. Data sources will include semi-structured interviews with the patients, and clinicians, as well as data from paper medical records, research logs, and server data. The results of the quantitative and qualitative data will be analyzed separately and then integrated at the interpretation and reporting levels to advance our understanding of the telemonitoring program's feasibility. This will be the first study to provide evidence on the feasibility of using a telemonitoring program where pregnant women at high-risk for preeclampsia in Pakistan will take their own blood pressure readings at home.",[31,570],"Pregnant With Complication",[572,573,574],"Telemonitoring","mHealth","Remote monitoring","2026-05-27",{"date":577,"type":50},"2026-06-01",{"date":532,"type":50},{"date":580,"type":23},"2027-03-31",{"name":582,"class":57},"University Health Network, Toronto",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":24,"phases":592,"briefSummary":593,"conditions":594,"keywords":596,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":58},"100640668","clinician-notification-to-increase-aspirin-prophylaxis-for-preeclampsia-prevention-100640668","NCT07614893","Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention","A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia","Inclusion Criteria:\n\n* Pregnant individuals receiving outpatient obstetric care at participating medical centers.\n* Age 18 years or older.\n* Currently pregnant and within 12 to 28 weeks' gestation\n* Identified as having elevated predicted risk for preeclampsia as defined by USPSTSF and ACOG criteria\n* Receiving care from a clinician, care team, or clinic participating in the randomized implementation trial.\n\nExclusion Criteria:\n\n* Known contraindication to aspirin prophylaxis documented in the electronic health record.\n* Pregnancy beyond the prespecified gestational age window for aspirin prophylaxis implementation at the time of eligibility assessment.\n* Not receiving ongoing obstetric care at a participating site.",{"count":591,"type":23},1000,[26],"Preeclampsia is a leading cause of maternal morbidity and mortality. Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice. This pragmatic cluster-randomized implementation trial will test whether clinician notification of elevated preeclampsia risk increases aspirin prophylaxis utilization among eligible pregnant individuals receiving outpatient obstetric care.\n\nClusters will be randomized to clinician notification versus usual care. In the intervention arm, obstetric clinicians will receive notification that a patient is at elevated risk for preeclampsia and a recommendation to consider initiation of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. The intervention does not assign participants to aspirin and does not require any study-mandated medication. All decisions regarding aspirin prophylaxis will remain at the discretion of the treating obstetric clinician and patient.",[31,260,383,595],"Aspirin Prophylaxis",[263,597],"aspirin prophylaxis","2026-05-22",{"date":600,"type":50},"2026-05-29",{"date":602,"type":23},"2027-05",{"date":604,"type":23},"2030-05",{"name":606,"class":57},"Massachusetts General Hospital",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":614,"targetDuration":4,"studyType":24,"phases":615,"briefSummary":616,"conditions":617,"keywords":622,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":58},"100582284","placental-imaging-techniques-100582284","NCT06861309","Placental Imaging Techniques","Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction","Inclusion Criteria:\n\n* Normal-Fetal-Weight Pregnancies Arm: Patient at least 18 to 45 years of age at screening\n* Normal-Fetal-Weight Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders or growth abnormalities\n* Normal-Fetal-Weight Pregnancies Arm: Low-risk aneuploidy screening, if performed\n* Normal-Fetal-Weight Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)\n* Normal-Fetal-Weight Pregnancies Arm: Anatomical survey has been performed\n* Normal-Fetal-Weight Pregnancies Arm: Pregnancy without current fetal growth restriction (FGR) diagnosis\n* Normal-Fetal-Weight Pregnancies Arm: Subject willing and able to provide informed consent Note: Verify that the most recent version of the ICF was used to consent the subject\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Patient at least 18 to 45 years of age at screening\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Low-risk aneuploidy screening, if performed\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Anatomical survey has been performed\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Pregnancy diagnosed with fetal growth restriction (FGR) by estimated fetal weight \\\u003C10th centile or abdominal circumference measurements \\\u003C10th centile\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Subject willing and able to provide informed consent Note: Verify that the most recent version of the ICF was used to consent the subject\n\nExclusion Criteria:\n\n* Normal-Fetal-Weight Pregnancies Arm: Multiple gestations\n* Normal-Fetal-Weight Pregnancies Arm: Known fetal anomaly affecting biometric measurements\n* Normal-Fetal-Weight Pregnancies Arm: Suspected fetal genetic disorder(s)\n* Normal-Fetal-Weight Pregnancies Arm: Suspected fetal infection(s)\n* Normal-Fetal-Weight Pregnancies Arm: Non-English or Spanish-speaking\n* Normal-Fetal-Weight Pregnancies Arm: Unstable housing or transportation\n* Normal-Fetal-Weight Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Multiple gestations\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Known fetal anomaly affecting biometric measurements\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal genetic disorder(s)\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal infection(s)\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-English or Spanish-speaking\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Unstable housing or transportation\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.",{"count":69,"type":23},[26],"The goal of this proof-of-concept, case-control, clinical trial is to evaluate the efficacy of using two newer ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), to evaluate the health of the placenta, visualize blood flow through the placental vasculature by color Doppler imaging in singleton pregnancies with and without fetal growth restriction (FGR).\n\n* Our primary objective is to investigate the ability of using these ultrasound technologies to distinguish healthy pregnancies from those affected by FGR, a condition characterized by a fetal weight below the 10th percentile for the gestational age or abdominal circumference of the pregnancy.\n* Secondary aims include longitudinal evaluation of differences in QUS and uPDI imaging over gestation and changes in these measures with evolution of utero-placental insufficiency including with the development of abnormal umbilical-artery Doppler testing, diagnosis of severe FGR, identification of stillbirth, and detection of preeclampsia or preterm birth.\n\nInvestigators will compare QUS\u002FuPDI imaging and values in pregnancies determined to be healthy by approved, standard-of-care growth ultrasounds to those diagnosed with FGR.\n\nParticipants will receive research ultrasounds with the experimental Verasonics Vantage 256 system (Verasonics, Inc, Kirkland, WA) utilizing uPDI\u002FQUS every three weeks following their routine growth ultrasound evaluation until delivery. Demographic, obstetric, and delivery-related information, as well as portions of subjects' past medical history will be utilized by researchers to further contextualize imaging and variables gathered during the research ultrasounds.",[382,618,31,619,77,383,620,621],"Placental Insufficiency","Still Births","Pregnancy Outcomes","Ultrasound",[623,624,625,626,627,621,77,383,628,629,630,631,632,633,78,31,634,635,636,637],"Fetal Growth Restriction","FGR","Placental Imaging","Utero-Placental Insufficiency","Growth Restriction","Maternal Fetal Medicine","Ultrafast Power Doppler Imaging","Quantitative Ultrasound","uPDI","QUS","MFM","Verasonics","Verasonics Vantage 256","Carilion Clinic","Virginia Tech","2026-05-20",{"date":598,"type":50},{"date":641,"type":50},"2025-04-23",{"date":643,"type":23},"2026-11",{"name":636,"class":57},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":652,"targetDuration":4,"studyType":24,"phases":653,"briefSummary":655,"conditions":656,"keywords":658,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":671},"100614636","phase-1-a-study-to-investigate-the-safety-pharmacodynamic-and-pharmacokinetic-characteristics-of-cbp-4888-in-hospitalized-participants-with-preterm-preeclampsia-and-their-children-up-to-24-months-100614636","NCT07282171","A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Characteristics of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia and Their Children up to 24 Months","An Open-Label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia Receiving Standard of Care, Expectant Management","Inclusion Criteria:\n\n* Hospitalized with a hypertensive disorder of pregnancy (preeclampsia) defined by elevated blood pressure after 20 weeks gestation with proteinuria or, in the absence of proteinuria, with evidence of organ dysfunction (e.g., thrombocytopenia, renal insufficiency, or impaired liver function), and expected to remain hospitalized through delivery\n* The subject has given written consent to participate in the study.\n* Pregnant participants aged 18 to 45 years of age\n* Gestational age at Day 1 between 26 weeks 0\u002F7 days and 35 weeks 6\u002F7 days\n* Deemed clinically stable and suitable for expectant management for at least 72 hours post CBP-4888 administration\n* The woman carries a singleton pregnancy\n* Anticipate that hospitalization will continue through delivery\n\nExclusion Criteria:\n\n* Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding.\n* Fetal growth restriction (\\\u003C3rd percentile, or \\\u003C10th percentile with abnormal Doppler) or known major chromosomal\u002Fgenetic abnormalities.\n* Maternal conditions requiring immediate delivery (e.g., severe hypertension, eclampsia, non-reassuring fetal status, pulmonary edema).\n* Known active maternal infections considered to potentially affect placental function.\n* Significant maternal medical conditions (e.g., HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder, lupus with nephritis\u002Fcerebritis).\n* Use of another investigational drug within 30 days prior to study entry.\n* Any other condition that, in the investigator's judgment, poses risk to mother or fetus.",{"count":69,"type":23},[654],"PHASE1","This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant Management. Eligible participants are between 26 +0\u002F7 and 35 +6\u002F7 weeks gestational age and clinically appropriate for inpatient expectant management. Eligible participants will receive standard of care expectant management for their pregnancy with the only study interventions being one subcutaneous dose of CBP-4888.\n\nParticipants will:\n\n* receive a single subcutaneous injection dose of CBP-4888 and will be followed through delivery and for 42 days (+14 days) after delivery. Participants will be followed through 6 weeks post delivery.\n* Infants will be evaluated immediately postpartum and then followed through 24 months of age with standard infant and pediatric assessments with phone calls made to parents.",[657,31,381],"sFlt1 Mediated Preterm Preeclampsia",[659,660,31],"preterm preeclampsia","Hypertensive disorder of pregnancy","2026-05-15",{"date":663,"type":50},"2026-05-18",{"date":665,"type":50},"2025-02-26",{"date":667,"type":23},"2029-03-31",{"name":669,"class":670},"Comanche Biopharma","INDUSTRY",3,{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":678,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":18,"minAge":66,"maxAge":680,"enrollmentInfo":681,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":682,"conditions":683,"keywords":684,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":58},"100551751","new-therapeutic-strategy-against-preeclampsia-100551751","NCT06464159","New Therapeutic Strategy Against Preeclampsia","New Therapeutic Strategy Against Preeclampsia : Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1 and Release of PlGF","APHERESE2","Inclusion Criteria:\n\n* Age from 18 to 50 years old\n* Singleton pregnancies between 20 and 41 weeks of gestation\n* Preeclampsia \u002F normal pregnancy\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Infectious disease: HIV, HBV or HCV\n* Multiple pregnancies\n* refusal to participate in the protocol\n* Lack of social security cover","50 Years",{"count":335,"type":23},"Preeclampsia is a hypertensive disorder of pregnancy associated with important maternal and perinatal mortality. It complicates 2 to 5% of pregnancies and causes more than 70 000 maternal deaths each year worldwide. Although symptomatic management has improved there is currently no curative treatment, and only childbirth and delivery of the placenta, usually prematurely, alleviate the mother's symptoms. The management of extremely preterm infants is a major societal challenge in medical, ethical and economic terms.\n\nPlacental insufficiency plays a central role in the pathophysiology of preeclampsia. Abnormal placentation during the first trimester leads to placental hypoperfusion, which induces trophoblast dysfunction and the release in maternal circulation of trophoblastic factors leading to the maternal symptoms. Among molecules that participate to the pathophysiology of preeclampsia, one of the most important players is soluble fms-like tyrosine kinase 1 (sFlt-1), which is a soluble form of the vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF) receptor. sFlt-1 binds to free VEGF and PlGF in the maternal circulation, thus reducing their bioavailability for their membrane receptors. Targeting the sFlt-1 pathway is one of the most promising strategies for the development of new treatments for preeclampsia. As sFlt-1 results from alternative splicing, its peptide sequence is identical to that of the extracellular part of the membrane receptor. The development of drugs that act specifically on the soluble form and not on the membrane form is therefore particularly complex.\n\nThe general objective of this research is to restore the angiogenic balance that maintains the physiological concentrations of free angiogenic factors in order to significantly prolong the pregnancy and diminish the consequences of the great prematurity. The precise objectives of the APHERESE 2 project are:\n\n1. To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column\n2. To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient",[31],[31,685,686,687,688,689,216,77],"Apheresis","Angiogenic factors","Maternal biomarkers","sFLt-1","PIGF","2026-04-30",{"date":692,"type":50},"2026-05-06",{"date":694,"type":50},"2026-02-10",{"date":696,"type":23},"2028-11",{"name":698,"class":57},"Assistance Publique - Hôpitaux de Paris"]