[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperemesis-gravidarum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperemesis-gravidarum":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,80,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652098","diagnostic-and-psychometric-validation-of-the-french-help-scale-in-hyperemesis-gravidarum-100652098",false,"NCT07767071","Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum","French-HELP","Inclusion Criteria:\n\n* The patient must be a member or beneficiary of a health insurance plan\n* Pregnant woman with nausea or vomiting that began during the first trimester of pregnancy (before 16 weeks of gestation) with no other identifiable cause.\n* Oral consent given by the participant\n\nExclusion Criteria:\n\n* The subject is in a period of exclusion determined by a previous study\n* The subject unable to provide consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Presence of a secondary cause for nausea and vomiting (hepatitis, pancreatitis, atypical forms of appendicitis, pyelonephritis, adnexal torsion, hyperthyroidism, or chronic treatments known to induce vomiting).\n* Presence of any pre-existing medical condition or situation that could cause vomiting (restrictive bariatric surgery, eating disorders).\n* Inability to complete the questionnaires (lack of French language comprehension, illiteracy, intellectual disability, etc.).\n* Patient enrolled in a study evaluating a treatment intended to address nausea and vomiting.","FEMALE","18 Years",{"count":19,"type":20},300,"ESTIMATED","OBSERVATIONAL","Severe forms of nausea and vomiting of pregnancy (NVP) are classified as hyperemesis gravidarum (HG). NVP is debilitating in approximately 35% of women impairing daily life and professional activities while negatively affecting family relationships. In 0.3% to 3.6% of pregnancies, the vomiting is intractable and represents the leading cause of hospitalization during the first trimester. Severity of symptoms can sometimes lead women to consider terminating the pregnancy or to decide against future pregnancies.\n\nThe most widely used tool for assessing NVP and HG is the PUQE score; it asks three questions regarding nausea, vomiting, and retching, and is scored from 1 to 15. A score of ≥13 classifies NVP as severe. However, the PUQE score does not include questions regarding quality of life, which is a key determinant of HG.\n\nAn international definition (the Windsor definition of HG) has been developed, extending beyond mere digestive symptoms. This definition includes: symptom onset in early pregnancy (before 16 weeks of gestation); severe nausea or vomiting; an inability to eat or drink normally; and significant limitation of daily activities or signs of dehydration. This definition aligns better with the full spectrum of symptoms associated with this condition. The US-based Hyperemesis Education and Research (HER) Foundation developed the HELP Score to better assess nausea and vomiting of pregnancy (NVP), particularly severe cases. The tool includes questions regarding the intensity of nausea and vomiting, along with nine additional questions covering hydration, nutrition, treatments and their efficacy, and quality of life. The HELP score ranges from 0 to 60, with scores of 33 to 60 classifying patients as severe; this offers greater scope for assessing levels of severity, and improvement, compared to the PUQE score, which is calculated on a 15-point scale with only 3 points allocated to the severity category.\n\nThe HELP score has proved more effective than the PUQE score at identifying patients with severe symptoms requiring intervention, in a study with several methodological limitations, such as reliance on an online questionnaire and a failure to adhere to diagnostic validation standards. Nevertheless, the lack of robust evidence warrants further research using more rigorous methodology to confirm the value of this scoring system.",[24,25],"Hyperemesis Gravidarum","Nausea and Vomiting of Pregnancy",[27],"HELP score","NOT_YET_RECRUITING","2026-08-11",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":20},"2026-08",{"date":36,"type":20},"2028-11",{"name":38,"class":39},"Centre Hospitalier Universitaire de Nīmes","OTHER",7,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100602896","phase-1-hyperemesis-gravidarum-risk-reduction-with-metformin-100602896","NCT07129473","Hyperemesis Gravidarum Risk Reduction With Metformin","Inclusion Criteria:\n\n* Ages 18-49\n* HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment)\n* Trying to conceive\n* Treatment Arm: willing to refrain from trying to conceive during their metformin dose titration period and before 2 weeks at maximum tolerated dose (up to 8 weeks total). Will use birth control or contraceptive device until maintenance dose.\n* Under care of a personal OB\u002FGYN or willing to establish care with a personal OB\u002FGYN before study start\n* Ownership of a personal scale (or willingness to obtain one for study use)\n* Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy\n* Treatment Arm: residing in California\u002FAlabama\n* Treatment Arm: normal blood panel (CBC) (e.g., white count, hemoglobin, platelets all within the normal range)\n* Treatment Arm: normal to mildly decreased creatinine levels (estimated GFR \\> 60 mL\u002Fmin\u002F1.73m²)\n* Survey\u002FComparator Arm: not currently taking metformin and do not plan to take metformin prior to pregnancy\n* Able and willing to provide written informed consent prior to initiation of any study procedures.\n* Demonstrates understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up.\n* English speaking\n* Regular cycles\n\nExclusion Criteria:\n\n* Allergic or adverse reaction to metformin-XR\n* Thalassemia\n* Cirrhosis and\u002For hepatic impairment\n* Decompensated heart failure\n* Daily\u002Fregular use of medications\u002Fsubstances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix)\n* Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication\n* Assisted Reproductive Technology\n* Excess alcohol consumption (\\> 7 standard drinks per week on average)\n* Pregnant\n* Not trying to conceive\n* Treatment Arm: Residing outside California\u002FAlabama\n* Treatment Arm: abnormal blood panel (CBC) (e.g., white count or platelets not within the normal range)\n* Treatment Arm: abnormal creatinine levels (estimated GFR \\\u003C 60 mL\u002Fmin\u002F1.73m² excluded from the study, signs of kidney disease)\n* Treatment Arm: current metformin use\n* Survey\u002FComparator Arm: current metformin use or plans to take metformin prior to pregnancy\n* Any medical\u002Fsurgical condition that the investigator feels would compromise the participant's participation in the study\n* Not able and willing to provide written informed consent prior to initiation of any study procedures.\n* Does not demonstrate understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up.\n* Not english speaking\n* Irregular cycles\n* Not willing to refrain from trying to conceive\u002Fuse birth control or contraceptive device until maintenance dose.",true,"49 Years",{"count":50,"type":20},224,"INTERVENTIONAL",[53,54],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate whether daily oral metformin extended-release (metformin-XR), taken prior to and in early pregnancy, can reduce the risk and severity of Hyperemesis Gravidarum (HG), a severe nausea and vomiting condition in pregnancy, in individuals aged 18-49 who have experienced HG in a previous pregnancy and are trying to conceive. Researchers also aim to better understand which individuals may respond well - or poorly - to metformin based on biological and clinical characteristics.\n\nThe main questions this study aims to answer are:\n\n1. Is metformin-XR well-tolerated when taken by non-pregnant individuals who have had HG in a previous pregnancy and are currently trying to conceive?\n2. How safe and tolerable is metformin-XR when taken at increasing doses over an 8-week titration period and continued through early pregnancy (or for up to 12 months after reaching maintenance dose if pregnancy does not occur)?\n3. Among those who become pregnant during the study, does pre-pregnancy metformin-XR use reduce the risk of HG coming back and lower the severity of nausea and vomiting symptoms?\n4. How does pre-pregnancy metformin-XR use affect pregnancy outcomes, postpartum health, and newborn health and development?\n5. Are there specific genetic, biomarker, demographic, or clinical features that predict whether someone is likely to benefit from metformin-XR or experience side effects that lead them to stop taking it?\n\nResearchers will compare a metformin treatment group to a survey-only group (comparator, no study drug) to see if metformin-XR is associated with improved outcomes, including reduced HG recurrence and better maternal and neonatal health indicators.\n\nParticipants will:\n\nComplete online questionnaires before pregnancy, during early pregnancy, and postpartum\n\n(Treatment group only) Take daily metformin-XR and attend three brief study visits\n\n(Treatment group only) Undergo blood draws at specified timepoints to assess safety and biological response",[24],[58,59,60,24,25,61,62,63,64,65,66,67,68],"Metformin","HG","Hyperemesis","NVP","severe Nausea and Vomiting of Pregnancy","sNVP","Nausea","Vomiting","Pregnancy","Pregnant","Morning Sickness","RECRUITING","2026-07-20",{"date":72,"type":32},"2026-07-22",{"date":74,"type":32},"2026-07-13",{"date":76,"type":20},"2031-03",{"name":78,"class":39},"University of Southern California",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":51,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100563413","randomized-study-of-a-dematerialized-management-for-post-emergency-gynecological-follow-up-100563413","NCT06615843","Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up","GYNAB","Inclusion Criteria:\n\n* Women aged 18 and 60 years\n* No consultation at the gynecological emergency department in the previous month and\u002For for the same pregnancy.\n* Requires post-emergency follow-up for one of the following clinical conditions:\n\n  * Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment\n  * Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU \\< 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \\< 5000, compliant patient, no contraindications for Methotrexate\n  * Early Pregnancy of Uncertain Viability (GLI): Early stage with a positive bHCG test, no visible gestational sac on ultrasound, no effusion, bHCG \\< 1500 IU\n  * Missed Miscarriage (GAM): Confirmed by an intrauterine gestational sac ≥ 25mm without an embryo or an intrauterine gestational sac with an embryo ≥ 7mm without visible cardiac activity, treated with Misoprostol\n  * First Trimester Bleeding (MTRt1): Moderate vaginal bleeding with an ongoing intrauterine pregnancy without hemodynamic instability\n  * Hyperemesis Gravidarum (VG): Severe vomiting before 12 weeks of pregnancy without severe criteria necessitating emergency follow-up\n\nExclusion Criteria:\n\n* Severe clinical intolerance, defined by:\n\n  * Signs of severe sepsis with unstable hemodynamics (TA with SBP \\\u003C 90 mmHg and FC ≥ 105 bpm)\n  * Abdominal defense or contracture\n  * Pain not controlled by level 1 analgesics (EVA \\\u003C7)\n  * Severe dehydration defined by a body weight loss of more than 10%\n  * Total food intolerance due to vomiting necessitating hospitalization\n  * Uncontrolled active hemorrhage\n* Significant ultrasound findings:\n\n  * Tubo-ovarian abscess ≥ 3 cm\n  * Significant intra-abdominal effusion\n* Non-French speaking patients\n* Inability to download or use the digital application due to precarious or isolated digital circumstances\n* Refusal to sign consent form\n* Patients under legal guardianship or court protection (tutelage, curatorship, or guardianship)\n* Patients not affiliated with a social security system","60 Years",{"count":89,"type":20},200,[91],"NA","The GYNAB study aims to compare patient satisfaction and clinical outcomes between dematerialized post-emergency gynecological follow-up using a connected health app and traditional in-person follow-up. Conducted by Drs. Laëtitia CAMPIN and Louis MARCELLIN at Hôpital Cochin, it is sponsored by Assistance Publique - Hôpitaux de Paris. The main objective is to assess patient satisfaction at day 7 on a scale from 0 to 10, considering symptom management, follow-up quality, and task performance. Secondary objectives include comparing satisfaction at day 28, PROM-ED scores for symptom relief, understanding, reassurance, and care planning at days 7 and 28, hospitalization rates, unscheduled consultations, surgical interventions, total hospital time by day 28, and physician satisfaction at 28 days. This randomized trial involves women aged 18-60 needing follow-up for conditions like genital infections, non-complicated ectopic pregnancies, unlocated pregnancy, first trimester metrorrhagia, miscarriages , and severe vomiting before 12 weeks. Inclusion criteria are women aged 18-60 needing specified follow-up. Exclusion criteria are severe clinical intolerance, severe criteria ultrasound findings, non-French speakers, and inability to use digital applications. The intervention group uses a connected health app for data collection and communication, logging symptoms and test results, with medical team notifications for urgent updates. The control group receives traditional in-person follow-up with scheduled consultations and emergency contact information. The study hypothesizes that digital follow-up will improve patient experience, reduce hospital visits, and provide comparable or superior satisfaction and clinical outcomes. The results could promote broader digital health adoption in various medical fields.",[94,95,96,97,24],"Genital Diseases, Female","Ectopic Pregnancy","Uncertain Viability of Pregnancy","Abortion, Missed",[99,100,101,102,103,104,105],"Gynecological Emergencies","Post-Emergency Follow-Up","Patient-Reported Outcome Measures (PROMs)","Digital Health","Patient satisfaction","Telehealth","Asynchronous Medical Follow-up","2026-04-20",{"date":108,"type":32},"2026-04-21",{"date":110,"type":32},"2025-06-30",{"date":112,"type":20},"2027-07-30",{"name":114,"class":39},"Assistance Publique - Hôpitaux de Paris",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":124,"targetDuration":4,"studyType":51,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":115},"100575491","tablet-ginger-versus-tablet-doxylamine-succinate-in-control-of-nausea-and-vomiting-in-pregnancy-100575491","NCT06772974","Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy","Comparison of Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy","GDNVP","Inclusion Criteria:\n\n* Pregnant women age\\>18 years\n* 5 to 8weeks of gestation and 8+1to11weeks\n* Attending OPD with signs and symptoms of nausea and vomiting with ultrasound confirmed pregnancy\n* 1st and 2nd gravida\n* Patients who will give consent\n\nExclusion Criteria:\n\n* Patients were hospitalized for Hyperemesis Gravidarum\n* Medical disorders like Diabetes Mellitus, Hepatic, Gastric, Pancreatic, Pyelonephritis, Thyroid and Psychological Disorder\n* Patients not responding to treatment after 1week will be excluded\n* Patients who will not give consent",{"count":125,"type":20},66,[91],"Nausea and vomiting are common GI symptoms of pregnancy. Multiple managing options have been used for NVP. Doxylamine succinate is used as first line treatment for NVP despite that alternative modalities such as ginger extracts and tablets is being explored.\n\nThis RCT will be conducted after taking ethical approval and informed consent, in Department of Gynecology, Aziz Bhatti Shaheed teaching hospital, Gujrat. Patients will be divided into two equal groups. One group will receive tablet ginger while other group will receive Doxylamine succinate tablets. Baseline PUQE score (3- 15 point scale) over 24 hour will be noted according to symptoms of nausea and vomiting following 7 days of treatment and then at 2nd and 3rd week. Comparison of the change in the severity of nausea from baseline scores (Post-therapy PUQE score - base line scores) in both groups will be considered for results.",[129,24],"Nausea Gravidarum",[64,65,66],"2025-01-15",{"date":133,"type":32},"2025-01-17",{"date":131,"type":20},{"date":136,"type":20},"2025-07-15",{"name":138,"class":39},"Nawaz Sharif Medical College"]