[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postpartum-depression-ppd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postpartum-depression-ppd":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,50,75,97,119,144,178,207,236,267,297,325,349,376,399,425,455,477,499,529,562,592,627,644,689],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100652477","treatment-with-repetitive-transcranial-magnetic-stimulation-in-peripartal-depression-100652477",false,"NCT07774559","Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression","PPD and rTMS","Inclusion Criteria:\n\n* Women aged 18 years or older\n* Currently pregnant or up to 12 months after childbirth at screening\n* Current depressive episode or clinically significant depressive symptoms consistent with peripartum depression, confirmed by clinical interview according to ICD-10 criteria\n* MADRS score of at least 7 at screening\n* Able to understand German or English\n* Able to provide written informed consent\n* Willing and able to attend study visits and complete rTMS procedures, EEG and ECG recordings, hair and sputum sampling, and study questionnaires\n* Stable antidepressant and\u002For psychotherapy treatment, or no current antidepressant medication and\u002For psychotherapy; participants should agree to maintain treatment stability during the study where clinically feasible\n* Previous rTMS treatment for depression is permitted\n\nExclusion Criteria:\n\n* Current or past seizure disorder, or previous rTMS-induced seizure\n* Primary psychotic disorder\n* Acute suicidality requiring a higher level of care\n* Contraindications to rTMS, including intracranial metallic implants; implanted neurostimulators; cochlear implants; vagus nerve stimulators; ocular implants; implanted cardiac electrodes or pacemakers; aneurysm coils or clips; ventriculo-peritoneal shunts; or other ferromagnetic or electronic implants in the head or neck\n* Clinically significant head injury within the previous 12 months or with relevant residual symptoms\n* Unstable or severe medical or obstetric complications that could make participation unsafe, such as preeclampsia or imminent preterm labour requiring intensive management\n* Severe substance use disorder that could interfere with safety or study assessments\n* Inability to follow study procedures, for example because of cognitive impairment\n* Frequent severe migraine, including chronic migraine with status migrainosus, if high-frequency rTMS is considered likely to worsen symptoms, unless the investigator and treating physician determine that participation is safe.","FEMALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether repetitive transcranial magnetic stimulation (rTMS) can reduce depressive symptoms in women who are pregnant or up to 12 months after childbirth and have peripartum depression. rTMS is a non-invasive treatment in which a device placed on the scalp delivers gentle magnetic pulses to a brain area involved in mood regulation. It does not involve medication or anaesthesia.\n\nThe main questions this study aims to answer are:\n\n* Does active rTMS reduce depressive symptoms more than sham rTMS?\n* What side effects occur during treatment, and how well is rTMS tolerated?\n* Are improvements in depressive symptoms still present one month after treatment?\n\nResearchers will compare active rTMS with sham rTMS, a treatment designed to feel and sound similar but not to provide effective brain stimulation. Neither participants nor the clinicians assessing depressive symptoms will know which treatment was assigned during the main study phase.\n\nUp to 60 women aged 18 years or older who are pregnant or up to 12 months after childbirth and have clinically relevant depressive symptoms may take part. Participants will:\n\n* Attend a screening and baseline visit, including questionnaires, EEG and ECG recordings, and collection of small hair and sputum samples to study stress-related hormone levels\n* Be assigned by chance to receive either active rTMS or sham rTMS\n* Attend 30 treatment sessions, scheduled flexibly over approximately 1.5 to 10 weeks to accommodate childcare, breastfeeding, fatigue, and medical appointments\n* Complete questionnaires about mood, wellbeing, quality of life, social support, and treatment expectations before and after treatment\n* Have safety and side effects checked before each treatment session\n* Complete a telephone follow-up assessment one month after treatment\n* Be asked to complete a short questionnaire about their child's development one year after treatment\n\nEach treatment visit lasts about 30 minutes, including preparation, treatment, and a short safety check. Infants may be brought to treatment visits when this can be done safely.\n\nrTMS is generally well tolerated. Possible temporary side effects include headache, scalp discomfort, facial muscle twitching during stimulation, dizziness, or tiredness. A seizure is a very rare but serious possible risk; therefore, people with epilepsy, certain implants, or other relevant risk factors cannot take part.\n\nParticipation is voluntary. Participants can pause or stop participation at any time without affecting their usual care. Personal data will be coded and handled confidentially. Women assigned to sham treatment will be offered active rTMS after the blinded study phase, if they wish. The results may help clarify whether rTMS is an effective non-medication treatment option for peripartum depression.",[27,28,29],"Depression During Pregnancy","Postpartum Depression (PPD)","Peripartum Depression",[31,32,33,34,35,36],"Peripartal depression","Postpartal depression","Antenatal depression","Repetitive transcranial magnetic stimulation","Transcranial magnetic stimulation","rTMS","NOT_YET_RECRUITING","2026-08-17",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":21},"2026-09",{"date":45,"type":21},"2030-08-31",{"name":47,"class":48},"Psychiatric University Hospital, Zurich","OTHER",2,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100651838","informing-implementation-of-a-circadian-focused-intervention-for-postpartum-depression-100651838","NCT07766161","Informing Implementation of a Circadian-Focused Intervention for Postpartum Depression","Inclusion Criteria:\n\n1. ≤ 6 months postpartum\n2. EPDS score \\>10\n\nExclusion Criteria:\n\n1. Current or past-year substance use disorder\n2. Lifetime history of bipolar disorder or psychotic disorder\n3. Active suicidal intent\n4. Retinal pathology or history of eye surgery\n5. Current use of photosensitizing medications\n6. Untreated sleep-disordered breathing, untreated restless legs syndrome, or narcolepsy\n7. Psychotherapy or psychotropic medications started\u002Fdose changed in past month (psychotherapy started and\u002For current medication at stable dose ≥ 4 weeks are permitted)\n8. Medical conditions contraindicated for mBLT (e.g., epilepsy\u002Fseizures)",{"count":57,"type":21},30,[24],"The proposed study is an open-label trial of Re-Timer® wearable morning bright light therapy for postpartum depression. The study is focused on evaluating the feasibility, acceptability, and implementation context of morning Bright Light Treatment (mBLT) for postpartum depression.",[28],[62,63],"Circadian rhythm","Light therapy","RECRUITING","2026-08-10",{"date":67,"type":41},"2026-08-14",{"date":69,"type":41},"2026-07-29",{"date":71,"type":21},"2027-05",{"name":73,"class":48},"University of Michigan",1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100628317","routine-vs-early-postpartum-depression-screening-a-pragmatic-clinical-trial-100628317","NCT07460063","Routine vs. Early Postpartum Depression Screening: A Pragmatic Clinical Trial","Inclusion Criteria:\n\n1. Live birth, term (≥37 weeks) delivery at Massachusetts General Hospital\n2. Access to Patient Gateway, as to receive the electronic EPDS scale\n3. Primary obstetric provider at MGH or its affiliated clinics\n4. No recent history of depressive disorder as determined through diagnoses or medication use\\*\n5. Age ≥18 years old\n\nExclusion Criteria:\n\n1. A diagnosis code in the EHR for major depressive disorder, bipolar disorder, or psychotic disorder within the year prior to delivery\n2. Antidepressant, antipsychotic, or bipolar medication use within the year prior to delivery\n3. Age \\\u003C18 years old",{"count":82,"type":21},428,[24],"After having a baby, some women develop a condition called postpartum depression, or PPD, which can cause sadness, anxiety, and difficulty bonding with their newborn. Right now, most women aren't screened for PPD until about 6 to 8 weeks after giving birth, but this study wants to find out if checking earlier could help identify signs sooner. To test this, researchers will work with 428 women who deliver at an MGH hospital clinic and have no history of depression. Each woman will be randomly placed into one of two groups: one group will fill out a short depression questionnaire online at 2 to 3 weeks after delivery, while the other group will follow the usual process and complete the same questionnaire at their regular 6-week visit. The results will go to each woman's doctor, who will decide if any follow-up care is needed, just like they normally would. The study will follow each participant for 6 months after delivery to see whether earlier screening makes a difference.",[28],[87,88,89],"postpartum","depression","depression screening",{"date":91,"type":41},"2026-08-12",{"date":43,"type":21},{"date":94,"type":21},"2028-01",{"name":96,"class":48},"Massachusetts General Hospital",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":74},"100637526","parents-and-babies-pilot-100637526","NCT07607613","Parents and Babies Pilot","Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention","PAB","Inclusion Criteria:\n\n* self-identify as LGBTQ+\n* 18 years old or older\n* live in the USA or territories\n* speak and understand English\n* Currently pregnant or within one year of childbirth\n* Endorse current mild depressive symptoms or risk factors for postpartum depression\n\nExclusion Criteria:\n\n* Are unable to consent\u002Fhave impaired decision making capacity\n* Have current active suicidal or homicidal ideation, active psychosis, or current mania\n* Are currently experiencing a severe depressive episode\n* Do not have audio and\u002For video capacity for attending group sessions remotely.",{"count":106,"type":21},16,[24],"The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring\u002Funderstanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.",[110,28],"Perinatal Depression","2026-08-03",{"date":113,"type":41},"2026-08-06",{"date":111,"type":41},{"date":116,"type":21},"2027-04",{"name":118,"class":48},"Northwestern University",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100648613","phase-3-a-study-of-mi078-for-postpartum-depression-100648613","NCT07721961","A Study of MI078 for Postpartum Depression","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Clinical Trial of MI078 Capsules for the Treatment of Patients With Postpartum Depression","Inclusion Criteria:\n\n* Female patients aged 18-45 years (inclusive) with a body mass index (BMI) of 18.5-37.0 kg\u002Fm² (inclusive).\n* Based on the investigator's clinical evaluation, the participant meets the diagnostic criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by clinical assessment and the Mini-International Neuropsychiatric Interview (M.I.N.I.), with onset of depression between gestational week 28 and 4 weeks postpartum (inclusive).\n* Within 12 months postpartum at baseline.\n* Total score ≥26 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline.\n* Understand and voluntarily participate in this trial, agree to comply with all study requirements, and provide written informed consent prior to any study-specific procedures.\n* Able to communicate well with the investigator, willing and able to comply with lifestyle restrictions or requirements specified in the protocol, and capable of completing the trial as required.\n\nExclusion Criteria:\n\n* Currently meeting diagnostic criteria for other DSM-5 psychiatric disorders, as assessed by the investigator.\n* History of bipolar disorder, schizophrenia, and\u002For schizoaffective disorder.\n* Reduction in HAM-D17 total score from screening to baseline ≥25%.\n* Presence of suicidal ideation\u002Fintent, or HAM-D17 Item 3 (suicide) score \\>3, or a \"yes\" response to Item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation in the past 6 months at baseline, or a history of suicidal behavior within 1 year.\n* Meeting diagnostic criteria for treatment-resistant depression.\n* Continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode.\n* Discontinuation of psychotropic medications for less than 5 half-lives prior to the first dose of study drug.\n* Need for concomitant use of other psychoactive drugs during the treatment period, including antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics (excluding non-benzodiazepines).\n* Discontinuation of strong CYP3A4 inducers or inhibitors for less than 5 half-lives prior to the first dose of study drug.\n* Receipt of systematic psychotherapy (e.g., interpersonal therapy, psychodynamic therapy, cognitive-behavioral therapy) or psychiatric-related acupuncture within 1 week prior to the first dose, or planned receipt of such treatments during the trial.\n* Receipt of other physical treatments for psychiatric disorders (e.g., modified electroconvulsive therapy, transcranial magnetic stimulation, psychiatric-related laser therapy, vagus nerve stimulation, deep brain stimulation, light therapy) within 1 month prior to screening.\n* Presence of severe or unstable cardiovascular, hepatic, renal, hematological, endocrine (e.g., uncontrolled hyper- or hypothyroidism), neurological (e.g., epilepsy, Parkinson's disease, multiple sclerosis, Huntington's disease, history of seizure disorder \\[except single febrile seizure in childhood\\]), gastrointestinal (e.g., history of gastrointestinal disease or surgery that may interfere with drug absorption, distribution, metabolism, or excretion), or other systemic or organ diseases, as judged by the investigator.\n* History of malignancy within 1 year prior to screening.\n* Participation in another drug trial within 3 months prior to screening, or participation in a medical device trial within 1 month prior to screening (defined as having received investigational drug or device treatment).\n* Major surgery (excluding cesarean section) within 1 month prior to screening, or planned surgery during the trial period.\n* History of hypersensitivity (allergy to at least 2 substances) or known allergy to progesterone.\n* Positive pregnancy test at screening or baseline (for participants who are 4 weeks postpartum, a positive result requires retesting), or unwillingness to use effective contraception throughout the trial and for at least 3 months after the last dose of study drug, or plans for oocyte donation during this period.\n* Clinically significant abnormal 12-lead electrocardiogram (ECG) or laboratory findings at screening or baseline that, in the investigator's opinion, may affect the trial, including but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× upper limit of normal (ULN), or serum creatinine \\>1.5× ULN.\n* Currently breastfeeding and unwilling to discontinue breastfeeding during the treatment period and for 7 days after the last dose.\n* Any physical\u002Fpsychological illness or condition that, in the investigator's opinion, may increase the risk of the trial, affect compliance with the protocol, or interfere with the completion of the study, or any other condition that the investigator deems unsuitable for participation in this trial.","45 Years",{"count":128,"type":21},200,[130],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression.",[28],"2026-07-18",{"date":135,"type":41},"2026-07-23",{"date":137,"type":41},"2026-07-10",{"date":139,"type":21},"2027-12",{"name":141,"class":142},"Nanjing Minova Pharmaceutical Co., Ltd.","INDUSTRY",36,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":151,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":162,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":74},"100592641","essential-coaching-postpartum-evaluating-a-parent-focused-postpartum-text-message-program-in-nova-scotia-100592641","NCT06996067","Essential Coaching Postpartum: Evaluating a Parent-focused Postpartum Text Message Program in Nova Scotia","INCLUSION CRITERIA:\n\nEligible birthing parents will\n\n* early postpartum (\\\u003C7 days) with their first child\n* understand English\n* have a cell phone with text and data\n* be 18 years of age or old\n* live in Nova Scotia.\n\nEligible non-birthing parents will:\n\n* be early postpartum (\\\u003C7 days) with their first child\n* understand English\n* have a cell phone with text and data\n* be 18 years of age or old\n* live in Nova Scotia.\n\nEXCLUSION CRITERIA:\n\nParticipants (both birthing and non-birthing parents) will be excluded if:\n\n* newborn die or are expected to die prior to leaving the hospital\n* they have no access to mobile phone, either personal or shared\n* unwilling to receive SMS messages\n* decline or withdraw to participate\n* participated in a previous iteration of this project (e.g., either the development or evaluation).",true,"ALL",{"count":153,"type":21},332,[24],"The transition to parenthood is often an exciting yet hard period for parents. In the first year after a new baby, many parents feel less confident, have more anxiety and depression, and feel more isolated and alone. During this time, many parents use their phones and the Internet to seek out information and support. Thus, the investigators are exploring the opportunity of using mHealth, or mobile health, to provide information directly to parents after the birth of their first baby. The investigators have developed a program for both birthing and non-birthing parents called the Essential Coaching Postpartum program. This program provides 332 parents with text messages sent for 6 weeks after birth to share information on newborn care and parent outcomes. This will be tailored based on whether they are the birthing parent (Essential Coaching for Every Mother) or non-birthing parent (Essential Coaching for Every Partner). The investigators will evaluate this program by comparing a group of parents who receive the messages to a group of parents do not receive any text messages. To determine the success of the Essential Coaching Postpartum program, the investigators will compare parents' confidence, anxiety, depression, and co-parenting between the two groups after six-weeks and six-months. The investigators believe that parents who get the text messages will have higher confidence and co-parenting outcomes and lower anxiety and depression. The investigator's goal with the Essential Coaching Postpartum program is to help make the first few weeks after a new baby less stressful by providing information and support directly to parents that they know they can trust.",[157,158,28,159,160,161],"Parenting Self-efficacy","Postpartum Anxiety","Postpartum Stress","Mental Health","Co-parenting Practices",[163,164,165,166,167,168],"text messaging","non-birthing parent","birthing parents","mothers","fathers","digital health","2026-07-02",{"date":171,"type":41},"2026-07-06",{"date":173,"type":41},"2025-06-05",{"date":175,"type":21},"2028-06",{"name":177,"class":48},"IWK Health Centre",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":151,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":49},"100645217","midwife-led-childbirth-review-and-psychological-outcomes-in-new-parents-100645217","NCT07678801","Midwife-led Childbirth Review and Psychological Outcomes in New Parents","Effects of a Midwife-led Childbirth Review on Psychological Outcomes in New Parents","CROWN","Inclusion Criteria:\n\nPregnant women: Age ≥ 18 years; Singleton pregnancy; Fluency in Czech; Women can enter the study without a partner; Live birth after enrollment. Partners: Partner of an enrolled woman; Age ≥ 18 years; Planning on being present at childbirth; Fluency in Czech\n\nExclusion Criteria:\n\nPregnant women: Age \\\u003C 18 years; Multi-fetal pregnancy; Not being able to read and speak fluent Czech; A severe medical condition including significant pregnancy complications preventing participation in the intervention or assessments; Stillbirth or neonatal death; Infant admitted to intensive care for a prolonged or life-threatening condition; Acute psychiatric condition (suicidality, psychosis, manic episode, substance abuse). Partners: Age \\\u003C 18 years; Not being able to read and speak fluent Czech; Not planning on being present at childbirth \u002F after recruitment: not present at childbirth; A severe medical condition preventing participation in the intervention or assessments; Stillbirth or neonatal death; Infant admitted to intensive care for a prolonged or life-threatening condition; Acute psychiatric condition (suicidality, psychosis, manic episode, substance abuse)",{"count":187,"type":21},1300,[24],"The aim of this clinical trial is to support psychological well-being and facilitate adjustment to parenthood among postpartum mothers and fathers through a midwife-led childbirth review (MLCR). MLCR is a structured 45-60-minute postpartum intervention focused on processing and integration of the individual's childbirth experience, involving active listening, emotional support, and provision of information. In this study, the investigators will employ the MLCR intervention developed by Gamble and Creedy (2009) for women with traumatic birth experiences, adapted for use in the general population of new parents, including both mothers and fathers\u002Fpartners. This study will compare the effectiveness of three MLCR models - MLCR provided within the first postpartum week, MLCR provided at 6-8 weeks postpartum, and MLCR provided at both time points - with standard postpartum care and with each other.",[28,191,192],"Perinatal Anxiety","Postpartum Mental Health",[194,195,196,197,198],"Postpartum debriefing","Perinatal mental health","Midwife-led childbirth review","Parenting","Postpartum adjustment","2026-06-25",{"date":201,"type":41},"2026-07-01",{"date":171,"type":21},{"date":204,"type":21},"2028-07-15",{"name":206,"class":48},"Charles University, Czech Republic",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":74},"100580168","phase-4-treatment-of-anaemia-after-caesarean-with-intravenous-versus-oral-iron-and-postpartum-depression-100580168","NCT06833788","Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression","Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression: a Multicentric Randomized Open-labelled Controlled Trial","IRON-DEP","Pre-inclusion criteria:\n\n* Age ≥18 years\n* Caesarean delivery (elective or in emergency)\n* Gestational age at delivery ≥ 32 weeks\n* 8.0 g\u002FdL ≤ postoperative Hb level ≤ 10.0 g\u002FdL measured within 72 hours postpartum\n* Informed consent form signed\n* Hospitalization in the postpartum maternity ward\n* National social security coverage including AME\n\nInclusion criteria:\n\n* Ferritinemia ≤ 100 ng\u002FmL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement\n* EPDS score in the immediate postpartum \\\u003C11 with a \"never\" answer to question n°10\n\nExclusion Criteria:\n\n* Stillbirth or neonatal death\n* Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) \\\u003C 35kg or \\> 100kg\n* Biermer disease\n* Hemochromatosis\n* Homozygous sickle cell disease or thalassemia\n* Chronic iron supplementation (outside pregnancy)\n* Known hypersensitivity or allergy to the studied drugs (IV or oral iron)\n* Contra-indication to the studied drugs (IV or oral iron)\n* Severe asthma (with daily background treatment)\n* Any known severe renal or liver disorder\n* Active acute infection\n* Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation\n* Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders\n* Participation in another clinical trial involving an intervention with the following risks:\n\n  * A change (increase or decrease in value) in Haemoglobin measured at 2 months postpartum OR\n  * A change in EPDS score measured at 2 and 6 months postpartum OR\n  * A trial exploring an intervention with a specific anaphylactic risk (reported as a potential adverse events in the protocol of the other trial) administered during the postpartum hospitalization period.\n* Poor understanding of the French language\n* Legal protection (curatorship or tutorship)",{"count":216,"type":21},2860,[218],"PHASE4","The objectif of the IRON-DEP Study is to assess the efficacy of intravenous (IV) versus oral iron treatment on the prevalence of postpartum depression (PPD) in women with moderate iron deficiency anemia after caesarean delivery.",[28],[222,223,224,225,226],"Postpartum depression (PPD)","Postpartum anaemia","Caesarean","Intravenous (IV) iron therapy","Oral iron therapy","2026-06-19",{"date":229,"type":41},"2026-06-23",{"date":231,"type":41},"2025-10-22",{"date":233,"type":21},"2028-10-30",{"name":235,"class":48},"Assistance Publique - Hôpitaux de Paris",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":254,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":265,"locationsCount":74},"100609439","nicu-utilization-of-remote-voice-technology-to-improve-maternal-experience-nurture-100609439","NCT07214597","NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)","NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial","NURTURE","Inclusion Criteria:\n\n1. Infant:\n\n   1. Admitted to the neonatal intensive care unit (NICU)\n   2. Not readmitted after discharge from the NICU\n   3. Expected to survive at least 2 weeks\n   4. Expected to be admitted to the NICU for at least 2 weeks\n   5. Singleton gestation\n2. Mother:\n\n   1. Age ≥ 18 years old\n   2. English speaking\n   3. Mother is the biological mother of the infant admitted to the NICU\n   4. Postpartum day 4 or less\n3. Partner (NOTE: Partner enrollment is not required)\n\n   1. Mother agrees to partner's participation\n   2. Designated by mother as support person with infant access\n\nExclusion Criteria\n\n1. Infant\n\n   a. Re-admission to NICU\n2. Mother\n\n   1. No access to an Android or iOS smartphone\n   2. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app\n   3. No personal email address\n   4. Incarcerated at time of delivery or postpartum\n   5. Inability to obtain informed consent\n\n   i. Patient's clinician refuses enrollment of the patient ii. Patient is either mentally (acute psychosis) or physically (intubated or critically ill in the ICU) unable to provide informed consent f. Unable to approach the patient (staffing, patient unavailable) g. Mother is not the intended parent (plans adoption, is a surrogate, will not have custody of the infant)\n3. Partner (NOTE: Partner enrollment is not required)\n\n   1. Age \\\u003C 18 years old\n   2. Not English speaking\n   3. Inability to obtain informed consent\n   4. No access to an Android or iOS smartphone that is different from the mother's smartphone\n   5. No access to an email address that is different from the mother's email address\n   6. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app",{"count":245,"type":21},150,[24],"The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.",[28,249,250,251,252,253],"Self-Efficacy","Parental Anxiety","Engagement, Patient","Usability","Length of Stay",[255,256,28,257,242,258],"Neonatal Intensive Care Unit","NICU","VoiceLove app","VoiceLove","2026-06-15",{"date":261,"type":41},"2026-06-17",{"date":263,"type":41},"2026-02-04",{"date":94,"type":21},{"name":266,"class":48},"Vanderbilt University Medical Center",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":126,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100609107","saint-in-postpartum-depression-ppd-100609107","NCT07210255","SAINT in Postpartum Depression (PPD)","A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression","Inclusion Criteria:\n\n1. Reproductive Women ages 18-45 at the time of consent.\n2. Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.\n3. 0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.\n4. If currently taking an antidepressant medication and\u002For receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.\n5. Severe depression as measured by MADRS ≥20 at screening.\n6. A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.\n7. Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.\n8. Agree to use effective contraception in the postpartum period for the study duration.\n9. Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.\n\nExclusion Criteria:\n\n1. Participant has attempted suicide in the last 6 months and\u002For expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.\n2. Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.\n3. Participant has active psychosis per investigator assessment.\n4. Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and\u002For obsessive-compulsive disorder.\n5. Participant has an active eating disorder or substance use disorder in the past 6 months and\u002For has a positive urine toxicity screen that the Principal Investigator (PI) deems exclusionary.\n6. Participant is using any exclusionary medications: high dose of benzodiazepines (\\>2mg lorazepam daily equivalent and\u002For \\>3 times per week) or medications that would interfere with treatment with TMS as per PI or designee discretion.\n7. Participant has a history of untreated or insufficiently treated sleep apnea.\n8. Participant has a history of significant neurologic disease, including developmental disability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure\u002Fepilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.\n9. Any untreated major somatic illness such as hypertension\u002Fcardiovascular disease\u002Fdiabetes\u002Fendocrine disorders etc.\n10. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).\n11. Contraindications to MRI (e.g., ferromagnetic metal in their body).\n12. Currently pregnant.\n13. History of receiving rTMS for any reason, as this may compromise blinding.",{"count":275,"type":21},192,[24],"This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment.\n\nIt will enroll 192 women within 12 months postpartum who are experiencing depression that has not improved with standard care, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.",[28],[280,281,282,283,284,285,286],"SAINT","Stanford Accelerated Intelligent Neuromodulation Therapy","Repetitive Transcranial Magnetic Stimulation (rTMS)","Intermittent Theta Burst Stimulation (iTBS)","Noninvasive Brain Stimulation","Postpartum depression","Neuromodulation","2026-05-12",{"date":289,"type":41},"2026-05-14",{"date":291,"type":41},"2025-11-01",{"date":293,"type":21},"2029-10-31",{"name":295,"class":142},"Magnus Medical",4,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":4},"100640076","mhealth-intervention-to-prevent-postpartum-depression-and-anxiety-in-chilean-women-wwwt-100640076","NCT07587177","mHealth Intervention to Prevent Postpartum Depression and Anxiety in Chilean Women (WWWT)","WHAT WERE WE THINKING\" (WWWT) PROGRAM: A DIGITAL INTERVENTION TO PREVENT POSTPARTUM DEPRESSION AND ANXIETY IN CHILEAN WOMEN","Inclusion Criteria:\n\n* First-time mothers (primiparous women)\n* Aged 18 years or older\n* Having a healthy, full-term infant younger than 2 months of age\n* Receiving prenatal or postnatal care at participating primary health centers in Chile\n* Having access to a mobile phone capable of receiving calls and text messages\n* Able to understand and communicate in Spanish\n\nExclusion Criteria:\n\n* Severe symptoms of depression or anxiety at baseline requiring immediate specialized mental health treatment\n* Severe psychosocial problems (e.g., substance abuse, domestic violence, significant cognitive impairment)\n* Infant born preterm or with severe medical conditions (e.g., genetic disorders or serious neonatal complications)\n* Inability to provide informed consent or participate in study procedures due to language or cognitive barriers",{"count":305,"type":21},220,[24],"The goal of this clinical trial is to evaluate the effectiveness of a digital psychoeducational intervention, \"What Were We Thinking\" (WWWT), to prevent the development of postpartum depression and anxiety symptoms in first-time mothers in Chile. The study includes adult women with a healthy, full-term infant younger than two months who are receiving care in primary health centers.\n\nThe main questions it aims to answer are:\n\n* Does participation in the WWWT intervention reduce depressive and anxiety symptoms at 3 months after the end of the intervention compared to usual care?\n* Does participation in the intervention improve maternal self-efficacy, perceived social support, and coparenting relationship quality compared to usual care? Researchers will compare an experimental group receiving the full WWWT intervention with a control group receiving usual care to determine the effectiveness of the intervention.\n\nParticipants will:\n\n* Complete self-report questionnaires assessing depressive symptoms, anxiety symptoms, maternal self-efficacy, perceived social support, and coparenting at baseline and at 3-month follow-up\n* Be randomly assigned to either the intervention group or the control group\n* Receive the WWWT intervention between 4 and 10 weeks postpartum (intervention group), including:\n\n  * Fourteen psychoeducational video modules (3-5 minutes each) delivered via text messaging over 4-5 weeks\n  * Individual contact with a trained facilitator through text messaging\n  * One virtual group session with other mothers and a facilitator\n* Continue receiving usual care in primary health services (control group) and receive a shortened version of the intervention after the follow-up assessment",[28,158],[310,311,195,312,313,314,315,316],"Postpartum depression prevention","Postpartum anxiety prevention","First-time mothers","mHealth intervention","Randomized controlled trial","Chile","What Were We Thinking (WWWT)","2026-05-08",{"date":289,"type":41},{"date":320,"type":21},"2026-05-01",{"date":322,"type":21},"2026-08-31",{"name":324,"class":48},"Universidad del Desarrollo",{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":74},"100630235","maternal-outcomes-mood-alcohol-use-and-depressive-symptoms-100630235","NCT07485036","Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms","Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms (MOMS-AD Pilot Study)","MOMS-AD","Inclusion Criteria:\n\n* Biologically female\n* Age ≥18 years\n* Within 12 months postpartum\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Serious medical or psychiatric conditions requiring hospitalization\n* Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychiatric disorder\n* Current use of psychoactive drugs, medication to treat problematic alcohol use, or depression\n* Participation in past 6 months in problematic alcohol use or substance use treatment\n* Unable to provide consent",{"count":57,"type":21},[24],"This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are:\n\n1. How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth?\n2. Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers?\n3. Is a CM-PST intervention practical for new mothers?\n\nThe researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage.\n\nParticipants will:\n\n* Complete 4 remote intervention sessions over 6 weeks\n* Conduct at-home urine drug tests 2x per week during the 6-week intervention\n* Answer online surveys about their mental health and alcohol use",[28,337,338,339],"Alcohol Use","Contingency Management","Problem Solving Therapy","2026-05-05",{"date":342,"type":41},"2026-05-11",{"date":344,"type":21},"2026-06-01",{"date":346,"type":21},"2027-11-30",{"name":348,"class":48},"University of Illinois at Chicago",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":357,"phases":4,"briefSummary":358,"conditions":359,"keywords":362,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":74},"100615441","maternal-expectations-on-labor-analgesia-and-risk-of-postpartum-depression-an-observational-study-100615441","NCT07292649","Maternal Expectations on Labor Analgesia and Risk of Postpartum Depression: An Observational Study","Inclusion Criteria:\n\n* Signed informed consent\n* Planned vaginal delivery (spontaneous or induced)\n* Pregnancy\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Language barrier\n* Contraindications to labor analgesia\n* Delivery by Cesarean section\n* Known history of psychiatric disorders (including major depression)",{"count":356,"type":21},3640,"OBSERVATIONAL","Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. The consequences are numerous, both physical and psychological, with long-term repercussions on the mother-infant bond, family dysfunction, and the development of emotional and cognitive disorders in children. The etiology of PPD is multifactorial, but numerous recent studies have focused on the role of labor pain and its management with labor analgesia techniques. The aim of the present study is therefore to assess whether there is a difference in the incidence of PPD between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.",[28,360,361],"Labor Analgesia","Expectations",[363,364,365,366],"postpartum depression","labor analgesia","epidural","expectations","2026-04-28",{"date":369,"type":41},"2026-04-29",{"date":371,"type":41},"2026-01-08",{"date":373,"type":21},"2029-06",{"name":375,"class":48},"University of Padova",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":395,"leadSponsor":397,"locationsCount":74},"100631518","intranasal-dexmedetomidine-for-postpartum-depression-prevention-100631518","NCT07501728","Intranasal Dexmedetomidine for Postpartum Depression Prevention","Intranasal Dexmedetomidine for Prevention of Postpartum Depression in Women Receiving Combined Spinal-Epidural Labor Analgesia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* ASA physical status II or III.\n* Age ≥ 18 years.\n* Singleton pregnancy, cephalic presentation\n* No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia for planned vaginal delivery\n\nExclusion Criteria:\n\n* History of bipolar disorder, psychiatric disorders, or suicidal ideation\n* Severe cardiac, cerebral, hepatic, or renal disease\n* Allergy to α2-adrenergic receptor agonists\n* Baseline bradycardia (heart rate \\\u003C 60 bpm) or cardiac conduction abnormalities before labor analgesia\n* Hypotension (systolic blood pressure \\\u003C 90 mmHg) before labor analgesia\n* History of drug or alcohol abuse\n* Severe rhinitis or nasal cavity deformity",{"count":384,"type":21},270,[24],"Brief Title: Intranasal Dexmedetomidine for Postpartum Depression Prevention: A Randomized Trial This study aims to evaluate the effect of intranasal dexmedetomidine (Dex) administered before combined spinal-epidural labor analgesia on the incidence of postpartum depression (PPD) in women undergoing vaginal delivery. This prospective, randomized, double-blind, placebo-controlled trial will enroll 270 parturients scheduled for vaginal delivery with neuraxial labor analgesia at Chengdu Jinjiang Maternal and Child Health Hospital from 2026 to 2027. Participants will be randomly assigned in a 1:1 ratio to receive either intranasal Dex (50 μg) or an equal volume of normal saline before the initiation of labor analgesia.\n\nPrimary Outcome Measure:\n\nIncidence of PPD at 42 days postpartum, defined as an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10\n\nSecondary Outcome Measures:\n\nIncidence of PPD at 7 days postpartum (EPDS ≥ 10) Sleep quality assessed by Numerical Rating Scale (NRS) and incidence of sleep disturbance (NRS ≥ 6) at 7 and 42 days postpartum Analgesic effect: NRS pain scores before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia Sedative effect: Ramsay Sedation Scale scores at the same time points Adverse events: bradycardia, hypotension, nausea\u002Fvomiting, respiratory depression, oversedation, intrapartum fever Labor characteristics: duration of first, second, and third stages of labor, and total labor duration Duration of labor analgesia Mode of delivery: spontaneous vaginal delivery or cesarean section Neonatal outcomes: Apgar scores at 1, 5, and 10 minutes, and NICU admission rate We hypothesize that intranasal Dex administered before labor analgesia will significantly reduce the incidence of PPD at 42 days postpartum compared to placebo. This study is expected to provide a novel, non-invasive, and effective strategy for PPD prevention in women undergoing vaginal delivery, thereby improving maternal mental health and neonatal outcomes.",[28],[389,390,360],"Postpartum Depression","Dexmedetomidine","2026-03-24",{"date":393,"type":41},"2026-03-30",{"date":320,"type":21},{"date":396,"type":21},"2027-04-01",{"name":398,"class":48},"Chengdu Jinjiang Maternity and Child Health Hospital",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":74},"100622488","evaluating-the-effectiveness-of-an-internet-based-therapy-icare-to-treat-symptoms-of-postpartum-depression-100622488","NCT07384273","Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression","iCARE","Inclusion Criteria:\n\n* Given birth within 6 months\n* Edinburgh Postnatal Depression Scale (EPDS) score above 7\n* ≥age 18\n* Access to the internet\n\nExclusion Criteria:\n\n* Do not understand Danish language,\n* Substance abuse or dependence\n* Alcohol abuse, defined by a weekly consumption of alcohol exceeding 10 units\n* A diagnosis of schizophrenia, other psychotic disorders or in immediate need of psychiatric treatment.",{"count":407,"type":21},352,[24],"Postpartum depression (PPD) is a common and serious condition affecting 9.5% of women in high-income countries, and around 8% in Denmark. It shares core features with major depression, including low mood, loss of interest, and impaired functioning. Untreated PPD can persist for months, negatively impacting maternal well-being, child development, and family dynamics. In Denmark, systematic screening using the Edinburgh Postnatal Depression Scale (EPDS) is standard practice, but access to PPD treatment varies widely across municipalities.\n\nCognitive behavioral therapy (CBT) is the most effective psychological intervention for perinatal depression, yet limited availability and long wait times create barriers to access to care. Internet-based CBT (iCBT) offers a scalable, cost-effective alternative that can be delivered flexibly at home. Evidence supports the efficacy of self-guided iCBT for depression, though challenges such as high dropout rates have been reported. International trials in Norway, Portugal, Iran, South Korea, and the US have shown promising results for iCBT in perinatal populations. Some recent iCBT based interventions have also incorporated elements of Acceptance and Commitment Therapy (ACT) - which emphasizes psychological flexibility via mindfulness-based acceptance and values-driven action-and have demonstrated efficacy in reducing postpartum depression symptoms. These kinds of interventions (either iCBT or iCBT + ACT) have not yet been tested and evaluated in Denmark.\n\nThis clinical trial aims to evaluate whether adding an iCBT intervention with elements from ACT (iCARE) to treatment as usual (TAU) is more effective than TAU alone in reducing depressive symptoms in mothers with symptoms of PPD.\n\nMoreover, a qualitative process evaluation of the iCARE will explore implementation, acceptability, and mechanisms of impact. Its primary aim is to understand how participants experience the iCARE intervention and TAU, focusing on implementation fidelity, acceptability, and contextual influences. The secondary aim is to explore perceived mechanisms of change (e.g., cognitive, emotional, behavioral) and barriers\u002Ffacilitators to engagement.",[28],[285,412,413,414,415],"Cognitive behavioural therapy","Internet-based therapy","Acceptance and commitment therapy","Randomised controlled trial","2026-02-03",{"date":418,"type":41},"2026-02-05",{"date":420,"type":41},"2026-02-01",{"date":422,"type":21},"2028-08-01",{"name":424,"class":48},"University of Southern Denmark",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":126,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":440,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":74},"100623421","telehealth-supported-breastfeeding-counseling-in-primiparous-mothers-100623421","NCT07396415","Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers","The Effect of Telehealth-Supported Breastfeeding Counseling on Breastfeeding Duration, Self-Efficacy, and Postpartum Depressive Symptoms: A Randomized Controlled Trial","TELE-BF","Inclusion Criteria:\n\n* Primiparous women aged 18-45 years.\n* Mothers who have delivered a healthy, term (≥37 weeks), singleton infant.\n* Ability to communicate in Turkish.\n* Willingness to participate in the study and provide informed consent.\n* Access to a telephone or internet-enabled device for telehealth communication.\n\nExclusion Criteria:\n\n* Mothers with severe maternal medical or psychiatric conditions that may interfere with breastfeeding.\n* Infants with congenital anomalies or conditions affecting feeding.\n* Mothers who require neonatal intensive care admission for their infants.\n* Mothers who are unable to participate in telehealth follow-up.",{"count":434,"type":21},100,[24],"Breastfeeding is critical for infant and maternal health; however, many first-time mothers experience difficulties that may lead to early discontinuation of breastfeeding. Telehealth-supported breastfeeding counseling has the potential to provide timely, accessible, and continuous support to mothers during the postpartum period.\n\nThis randomized controlled trial aims to evaluate the effect of telehealth-supported breastfeeding counseling on breastfeeding duration, breastfeeding self-efficacy, and postpartum depressive symptoms in primiparous mothers. Participants will be randomly assigned to either a telehealth-supported breastfeeding counseling group or a routine postpartum care group.\n\nThe intervention group will receive structured breastfeeding counseling sessions delivered via telecommunication tools in addition to standard care, while the control group will receive routine postpartum care only. Outcomes will be assessed using validated questionnaires and follow-up evaluations during the postpartum period. The findings of this study may contribute to improving breastfeeding support strategies and maternal mental health outcomes.",[438,28,439],"Breastfeeding","Breastfeeding Self-Efficacy",[441,442,443,444,445],"Breastfeeding Counseling","Telehealth","Primiparous Mothers","Postpartum Period","Randomized Controlled Trial","2026-02-02",{"date":448,"type":41},"2026-02-09",{"date":450,"type":21},"2026-02-25",{"date":452,"type":21},"2027-02-25",{"name":454,"class":48},"Marmara University",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":357,"phases":4,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":74},"100622339","a-mobile-application-for-early-detection-and-symptoms-trajectories-of-postpartum-depression-using-ecological-momentary-assessment-ema-100622339","NCT07382336","A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA)","A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA): A Prospective Cohort Validation Study","EMA For PND","Inclusion Criteria:\n\n* Pregnant women in their first and second trimesters.\n* Aged 18 years and older.\n* Able to read and understand Chinese\n* Own a smartphone with iOS or Android system.\n\nExclusion Criteria:\n\n* Psychiatric diagnosis (e.g., schizophrenia, intellectual disability or mood disorders), comorbid brain conditions (history of epilepsy, stroke, or brain tumors), or learning disabilities.",{"count":464,"type":21},120,"This pilot study will recruit 120 perinatal pregnant women and follow them up for 6 months. Both momentary and retrospective assessments of emotional well-being and psychosocial factors will be conducted on a mobile application. We aim to understand the symptom trajectories and provide evidence for effective individualized interventions.",[28],[468,285],"Ecological momentary assessment","2026-01-30",{"date":416,"type":41},{"date":472,"type":41},"2023-10-01",{"date":474,"type":21},"2026-04",{"name":476,"class":48},"The Hong Kong Polytechnic University",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":74},"100621392","the-effect-of-lullaby-during-bath-time-on-mother-infant-bonding-postpartum-depression-and-parental-self-efficacy-in-infants-100621392","NCT07370025","The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants","Inclusion Criteria:\n\n* Mothers who have had an uncomplicated pregnancy and delivery\n* Mothers who are healthy enough to care for their baby\n* Mothers who have suitable conditions at home to bathe their baby\n* Babies born at term (≥ 37 weeks of gestation) and with stable general health after birth\n\nExclusion Criteria:\n\n* Mothers with a history of serious postpartum complications (such as postpartum hemorrhage)\n* Mothers diagnosed with psychiatric illness\n* Mothers who are unable to participate directly in the care of their baby (due to severe disability, mandatory bed rest, etc.)\n* Mothers who cannot participate in the lullaby program due to hearing impairment\n* Infants who experience serious respiratory, cardiac, or neurological problems at birth or thereafter, who have a skin disease or dermatological condition that limits bathing, who have a history of admission to the neonatal intensive care unit, or who have a chronic disease or congenital anomaly",{"count":484,"type":21},98,[24],"This randomized, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. The postpartum period represents a critical phase for maternal psychological adjustment, during which stress, depressive symptoms, and low parenting confidence may negatively affect the quality of mother-infant interaction and bonding. Low-cost, culturally meaningful, and non-pharmacological interventions that support maternal well-being and early bonding are therefore of particular importance.\n\nThe study will be conducted with mothers who have delivered healthy term infants in a public hospital. Eligible participants will be randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive a structured bathing education and will be instructed to bathe their infants three times per week for two consecutive weeks while singing a lullaby using their own voice in a calm and quiet home environment. Live-recorded music will not be used. The intervention emphasizes sensory interaction, emotional closeness, and maternal voice as key components. Each bathing session is expected to last approximately 10-15 minutes. The control group will receive routine postpartum care without a structured lullaby-based bathing intervention.\n\nOutcome measures include mother-infant bonding, postpartum depressive symptoms, and perceived maternal parenting self-efficacy. Data will be collected at two time points: prior to hospital discharge (within the first 24 hours postpartum) and at the end of the two-week intervention period. Validated self-report instruments will be used for all outcome assessments.\n\nThe findings of this study are expected to provide evidence on the effectiveness of a simple, culturally embedded caregiving practice in supporting maternal mental health, strengthening mother-infant bonding, and enhancing parenting confidence during the early postpartum period. Results may inform postpartum care practices, parental counseling programs, and midwife-led supportive interventions.",[488,489,490,28],"Newborn Infant","Bonding","Self Efficacy","2026-01-28",{"date":469,"type":41},{"date":494,"type":21},"2026-05-15",{"date":496,"type":21},"2027-01-15",{"name":498,"class":48},"Istanbul University - Cerrahpasa",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":515,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":74},"100617121","prenatal-exercise-including-perineal-massage-and-maternal-neonatal-outcomes-100617121","NCT07314502","Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes","Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes: A Randomized Controlled Trial","PEPM-RCT","Inclusion Criteria:\n\n* Age ≥ 18 years；\n* Gestational age between 8 and 16 weeks\n* No contraindications to exercise；\n* Able to attend in-person exercise classes；\n* Having obtained hospital approval to participate in this exercise program；\n* Able to carry out basic communication in Mandarin Chinese;\n* Planning to deliver at the same maternal and child health hospital.\n\nExclusion Criteria:\n\n* Unable to deliver at the same hospital due to personal reasons；\n* Currently participating in other research projects；\n* Presence of absolute contraindications to exercise；\n* Uncertain about being able to attend three in-person exercise sessions per week；\n* Unable to communicate in Mandarin Chinese.",{"count":508,"type":21},2000,[24],"The study is divided into three phases:\n\nPhase 1: Baseline survey to obtain an overall understanding of the current situation of voluntary participation in prenatal perineal massage.\n\nPhase 2: Follow-up survey to further assess the current situation of voluntary prenatal exercise and prenatal perineal massage.\n\nPhase 3: Implementation of an intervention combining prenatal exercise and perineal massage.\n\nThe goal of this clinical trial is to learn whether a combined prenatal program of supervised, moderate-intensity exercise plus professionally administered antenatal perineal massage can improve maternal and newborn outcomes and can be safely implemented as part of routine antenatal care in healthy pregnant women receiving care at participating hospitals.\n\nThe main questions it aims to answer are:\n\n1. Does the combined prenatal program reduce urinary incontinence during pregnancy and after delivery?\n2. Does the combined prenatal program reduce depressive symptoms during pregnancy and in the postpartum period?\n3. Does the combined prenatal program lower the risk of gestational diabetes mellitus?\n4. Does the combined prenatal program reduce neonatal complications, including macrosomia?\n5. Do spontaneous, self-initiated prenatal exercise and structured, supervised prenatal exercise differ in their effects on maternal and neonatal outcomes ()?\n\nResearchers will compare the combined prenatal program to usual antenatal care to determine whether the intervention improves maternal and neonatal outcomes and is safe, feasible, and acceptable in a real-world clinical setting.\n\nParticipants will:\n\n1. Be screened and enrolled during pregnancy and complete baseline and follow-up assessments during pregnancy and after delivery.\n2. Be randomly assigned to either an intervention group or a usual-care control group.\n3. If assigned to the intervention group, attend supervised moderate-intensity exercise sessions three times per week (approximately 60 minutes per session) throughout pregnancy and receive antenatal perineal massage delivered by trained health professionals during late pregnancy.\n4. Provide questionnaire-based information and clinical data collected during routine visits and from medical records for outcome evaluation.",[512,28,513,514],"Postpartum Urinary Incontinence","Neonatal Complications","Gestational Diabetes",[516,517,389,518,519],"Exercise","Urinary Incontinence","Macrosomia","Pregnancy","2025-12-17",{"date":522,"type":41},"2026-01-02",{"date":524,"type":21},"2026-01-01",{"date":526,"type":21},"2029-12-31",{"name":528,"class":48},"South China Normal University",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":74},"100613873","narrative-nursing-for-cesarean-mothers-anxiety-and-breastfeeding-confidence-100613873","NCT07272252","Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence","Psychological Effects and Breastfeeding Self-Efficacy of a Structured Four-Step Narrative Nursing Intervention in Cesarean Mothers: A Randomized Controlled Mixed-Methods Study","NARRCARE","Inclusion Criteria:\n\n1. Women aged 18-50 years\n2. Scheduled for elective or non-emergency cesarean section at ≥37 weeks\n3. Able to communicate in Mandarin and provide written informed consent\n4. Expected hospital stay ≥24 h\n5. Singleton pregnancy with stable maternal and neonatal condition allowing routine mother-baby contact\n\nExclusion Criteria:\n\n1. Severe psychiatric disorders (schizophrenia, bipolar disorder, active suicidal ideation)\n2. Maternal or neonatal need for ICU\u002FNICU admission\n3. Emergency cesarean section preventing baseline assessment\n4. Communication or cognitive impairment precluding interview","50 Years",{"count":539,"type":21},160,[24],"This study tests whether a nurse-led \"4-step narrative nursing\" program can reduce anxiety and improve breastfeeding confidence in mothers who are having a planned or non-emergency cesarean section.\n\nWhat is the problem? About 30-40% of Chinese cesarean mothers feel high anxiety after surgery, and 1 in 5 is at risk for postpartum depression. Low confidence in breastfeeding is also common.\n\nWhat will we do?\n\nWe will randomly assign 160 mothers (1:1) to either:\n\nUsual care - standard education and ward care, or\n\nUsual care plus narrative nursing - four short (10-20 min) conversations with a trained nurse:\n\nBefore surgery - help the mother talk about her fears. 24-48 h after surgery - encourage her to \"name\" pain or worries and separate them from herself.\n\nBefore discharge - guide her to find positive moments and build a \"strong-mom\" story.\n\nTwo weeks later by phone - strengthen the new story and review feeding success. What will we measure? Main result: anxiety score at 48 h (STAI scale). Other results: depression risk, breastfeeding confidence, pain, and feeding rates up to 3 months.\n\nPossible benefits:\n\nLower anxiety, better mood, higher breastfeeding rates. No drugs or extra procedures are involved, only talking.\n\nRisks:\n\nMinimal; some mothers may feel emotional during conversations, but nurses can pause or refer to counselling if needed.",[158,28,439,543],"Cesarean Section Wound",[545,546,547,548,549,550,551,552],"narrative nursing","storytelling intervention","cesarean section","postpartum anxiety","breastfeeding confidence","mixed-methods","randomized controlled trial","China","2025-12-11",{"date":555,"type":41},"2025-12-18",{"date":557,"type":41},"2025-10-01",{"date":559,"type":21},"2026-03-01",{"name":561,"class":48},"Xi Huang",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":580,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":74},"100614469","effect-of-a-respectful-maternity-care-based-action-plan-in-postpartum-care-on-maternal-and-neonatal-outcomes-100614469","NCT07280000","Effect of a Respectful Maternity Care-Based Action Plan in Postpartum Care on Maternal and Neonatal Outcomes","The Effect of the Action Plan Developed Within the Framework of Respectful Maternity Care in Postpartum Care on Maternal and Neonatal Outcomes","Inclusion Criteria:\n\n* Postpartum women aged 18 years and older\n* Gave birth at 37-42 gestational weeks (vaginal or cesarean)\n* Have a single, healthy newborn\n* No chronic medical conditions\n* No history of high-risk pregnancy or fetal complications\n* No communication barriers (e.g., visual or hearing impairment)\n* Able to speak and understand Turkish\n* Literate and able to read and write in Turkish\n\nExclusion Criteria:\n\n* Development of maternal or neonatal complications during the postpartum follow-up period\n* Inability to reach the mother at the 8-week postpartum follow-up","49 Years",{"count":571,"type":21},500,[24],"This study will examine whether a Respectful Maternity Care-based action plan can improve the quality of postpartum care and maternal and newborn outcomes. Nurses and midwives will receive a three-day interactive training about respectful, evidence-based postpartum care. After training, a unit-level action plan will be implemented, including supportive visits, educational materials, and feedback meetings. Women receiving routine postpartum care before the intervention will be compared with women receiving care after implementation. Outcomes will include respectful maternity care experiences, maternal satisfaction, exclusive breastfeeding at 6-8 weeks, maternal mental health, mother-infant bonding, and postpartum complications. The goal of this study is to promote respectful, high-quality postpartum care and improve the health and well-being of mothers and newborns.",[575,576,577,28,438,578,579],"Postpartum Care","Maternal Health Care","Newborn Health","Quality of Care","Maternal Satisfaction",[581,575,582,577],"Respectful Maternity Care","Maternal Health","2025-12-01",{"date":585,"type":41},"2025-12-12",{"date":587,"type":21},"2025-12-10",{"date":589,"type":21},"2026-12-01",{"name":591,"class":48},"ilayda sel",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":357,"phases":4,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":74},"100607265","a-study-of-a-test-for-postpartum-depression-at-home-100607265","NCT07186309","A Study of a Test for Postpartum Depression at Home","A Prospective Validation of the Enlighten Device in Predicting Postpartum Depression Using At-Home Sample Collection in Both Blood and Saliva","BRAVE","Inclusion Criteria:\n\n* subject must be pregnant (singleton pregnancy)\n* \\\u003C30 weeks' gestation, age 18 or above\n* able to provide written consent in English\n\nExclusion Criteria:\n\n* The study team and\u002For PI may exclude anyone deemed unsafe to participate in the protocol.",{"count":601,"type":21},1000,"The study will seek to prospectively validate the Enlighten Device for prediction of PPD by examining true\u002Ffalse positive and negative rates of the test using PPD outcomes collected through 3 months postpartum; compare the accuracy of biomarkers and algorithm in determining risk for PPD in blood compared to saliva; determine the utility of a week 6 sample collection in identifying women who are currently experiencing PPD thus bringing them to clinical attention.\n\nOur population will consist of pregnant women aged 18 and older up to 33 weeks of gestation. This research involves two groups of potentially vulnerable subjects: pregnant women and their infants. Because this is a study of postpartum depression (PPD), inclusion of these two vulnerable subjects is required. The study will enroll 1000 pregnant non-adolescent women of childbearing age who meet eligibility criteria.\n\nThis project will address the following Aims:\n\nSpecific Aim 1: Prospective collection of true\u002Ffalse positive and negative PPD outcomes through 3 months postpartum.\n\nPrimary Hypothesis H1a: 80% or greater of pregnant women who develop postpartum depression (PPD) by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Test in T3.\n\nPrimary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Test in T3 will develop PPD by 3 months after delivery.\n\nExploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, \\& sociocultural context.\n\nSpecific Aim 2: Comparison of prospective biomarker calls made in blood samples compared to saliva samples using the Enlighten Test.\n\nPrimary Hypothesis H2: Biomarker calls made using blood versus saliva samples will demonstrate a high concordance rate of 75% or higher.\n\nExploratory Aim 2: In individuals who develop PPD by 3 months postpartum, conduct an epigenome-wide study (EWAS) in saliva to identify saliva-specific epigenetic biomarkers to improve the algorithm's ability to predict PPD using saliva in the third trimester and Week 6 samples.\n\nSpecific Aim 3: Determination of the utility of the Enlighten Test in identifying women currently experiencing PPD at W6 postpartum.\n\nPrimary Hypothesis H3: 80% of women who meet criteria for PPD at W6 will be Biomarker Positive.\n\nParticipants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester completed by mobile phlebotomists in-person through ExamOne (\\~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, and 3 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.",[28,519],[519,389,605,606,607,608,609,610,611,612,613,614,615,616,617],"Predictive Test","Blood Test","Third Trimester","Behavioral Symptoms","Mood Disorders","Mental Disorders","Puerperal Disorders","Pregnancy Complications","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Depression, Postpartum","Depression","Depressive Disorder","2025-11-25",{"date":620,"type":41},"2025-11-28",{"date":622,"type":41},"2025-11-20",{"date":624,"type":21},"2030-08",{"name":626,"class":48},"University of Virginia",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":632,"eligibilityCriteria":599,"healthyVolunteers":150,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":357,"phases":4,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":49},"100580028","clinical-validation-of-a-predictive-test-for-postpartum-depression-100580028","NCT06831968","Clinical Validation of a Predictive Test for Postpartum Depression","PREVAIL",{"count":571,"type":21},"The goal of this observational study is to develop a blood test that may be predictive of postpartum depression. This Blood test is investigational and not yet FDA approved. Participants will not receive the results of this blood test.\n\nUp to 500 pregnant women will be recruited for the study from 2 sites. Participants must be age 18 or above with a singleton pregnancy and able to provide written consent in English.\n\nThe Objective of this Clinical Trial is to prospectively validate the Enlighten Device test by prospectively determining false\u002Ftrue positive and negative rates. Building off of this, an exploratory objective of this study is to examine clinical factors associated with false positive\u002Fnegative rates.\n\nThis project will address the following Aim:\n\nAim 1: Prospective collection of true\u002Ffalse positive and negative PPD outcomes through 6 months postpartum.\n\nPrimary Hypothesis H1a: 80% or greater of pregnant women who develop PPD by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Device in T3.\n\nPrimary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Device in T3 will develop PPD by 3 months after delivery.\n\nExploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, and sociocultural context.\n\nParticipants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester (\\~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, 3 months, and 6 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.",[28,519],[519,389,605,606,607],{"date":638,"type":41},"2025-12-03",{"date":640,"type":41},"2025-03-20",{"date":642,"type":21},"2028-07-31",{"name":626,"class":48},{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":537,"enrollmentInfo":652,"targetDuration":4,"studyType":22,"phases":654,"briefSummary":655,"conditions":656,"keywords":673,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":685,"leadSponsor":687,"locationsCount":74},"100598934","comparing-integrative-midwife-led-vs-fragmented-inpatient-postpartum-care-impact-on-satisfaction-and-transition-to-motherhood-100598934","NCT07077941","Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood","Supporting Mothers With Integrative Care by Midwives for Lifelong Empowerment (SMILE): A Randomized Controlled Trial Comparing Midwife-led Integrative and Fragmented Standard Inpatient Postpartum Care Models on Maternal Satisfaction and Transition to Motherhood","SMILE","Inclusion Criteria:\n\n* Women aged 18 to 50 years at the time of delivery\n* Classified as \"low-risk\" by the obstetric team in the delivery room\n* Gestational age at birth between 36+0 and 42+0 weeks\n* Singleton birth (only one child born)\n* Intent to breastfeed\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Women younger than 18 or older than 50 at the time of delivery\n* Classified as \"high-risk\" by the obstetric team\n* Multiple birth (e.g., twins, triplets)\n* No intention or ability to breastfeed the newborn",{"count":653,"type":21},784,[24],"The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied. One is a nurse-led, seperate model of care and the other is a midwife-led, integrative model of care. Participants are healthy women between the ages of 18 and 50. They gave birth between 36+0 and 42+0 weeks of pregnancy and had a child. The type of birth is not an inclusion or exclusion criteria. Our hypotheses are: i) that maternal satisfaction with care in a midwife-led, integrative care model is higher than in separate maternal and infant care; ii) that a positive postpartum experience leads to earlier and increased maternity competence; iii) that a higher breastfeeding rate at the time of the survey in the fourth month can be achieved through integrative care. Participants will be randomly assigned, after birth of their child, to either the group cared for by a nurse or the group cared for by a midwife.",[657,658,659,660,661,28,160,662,663,664,665,666,667,668,669,670,671,672],"Maternal Health Services","Infant, Newborn","Postnatal Care","Breast Feeding","Maternal-Child Relations","Lactation","Breast Feeding, Exclusive","Patient Satisfaction and Experience With Integrative Therapies","Neonatal Jaundice","Maternal Behavior","Body Weight Decreased","Breast Feeding of Healthy Full Term Infants","Lactation Mastitis","Lactation Disorder - Postpartum Condition or Complication","Lactation Disorder With Baby Delivered","Lactation; Insufficient, Partial",[674,675,676,677,678,679,680],"Postnatal care","inpatient","maternity competence","satisfaction","integrative care","breastfeeding","maternal behavior","2025-07-12",{"date":683,"type":41},"2025-07-22",{"date":557,"type":21},{"date":686,"type":21},"2026-12-31",{"name":688,"class":48},"Medical University of Vienna",{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":4,"eligibilityCriteria":695,"healthyVolunteers":150,"sex":17,"minAge":696,"maxAge":697,"enrollmentInfo":698,"targetDuration":4,"studyType":22,"phases":700,"briefSummary":701,"conditions":702,"keywords":703,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":296},"100569735","salutogenesis-and-self-efficacy-based-childbirth-education-programme-for-preventing-postpartum-depression-100569735","NCT06698107","Salutogenesis and Self-efficacy-based Childbirth Education Programme for Preventing Postpartum Depression","Effectiveness of Childbirth Education Based on Salutogenic Perspective and Self-Efficacy Theory in Preventing Postpartum Depression Among Ethiopian Teenage Mothers: a Pilot RCT Study","Inclusion Criteria:\n\n* married first-time teenage mothers aged 13-19 years attending antenatal follow-up in the selected hospitals\n* a single pregnancy with 28-30 weeks of gestational age\n* no pregnancy complications contraindicating vaginal delivery\n* plan to have institutional delivery and postnatal visits at the selected health hospitals and who reside for a minimum of 12 weeks postdelivery around the selected hospitals\n\nExclusion Criteria:\n\n* have self-reported history or current mental health problems\n* participated in similar interventional programmes\n* have serious medical and obstetrics problems\n* having foetus with diagnosed congenital anomalies","13 Years","19 Years",{"count":699,"type":21},130,[24],"Although the transition to motherhood is often a joyful experience, there is evidence that teenage motherhood can present many stressful challenges, potentially leading to the development of postpartum depression. Postpartum depression (PPD) remains a public health issue with negative consequences for both mothers and their babies. The aim of this study is to assess the feasibility of implementing childbirth education underpinned by salutogenic and self-efficacy perspectives among teenage mothers in low-income settings. The study also aims to provide preliminary findings on the intervention's effectiveness in preventing postpartum depression among Ethiopian teenage mothers. The theoretical based childbirth education approach can enhance the psychosocial well-being of first-time teenage mothers. The intervention consists of six sessions: three during the antenatal period and three in the postpartum period. These sessions contain two individual face-to-face educations (each lasting 60-90 minutes), two phone calls (each lasting 30 minutes), and two group discussion (each lasting 90-120 minutes), as supported by the existing evidence. The study expected to support the feasibility of the study design. Preliminary findings are anticipated to show a significant difference in postpartum depression scores between the intervention and control groups, with teenage mothers in the intervention group having a lower risk of postpartum depression compared to those in the control group. Integrating sense of coherence and self-efficacy theories into maternity care services could provide empirical support for preventive efforts against postpartum depression. The findings of this study may address research gaps regarding the psychosocial wellbeing of teenage mothers, serving as baseline evidence for large scale interventional studies that consider the sociocultural and economic contexts of low-income countries.",[28],[285,704,705,706],"Teenage mothers","Intervention","Childbirth education","2025-03-11",{"date":709,"type":41},"2025-03-12",{"date":711,"type":41},"2024-12-05",{"date":713,"type":21},"2025-07-15",{"name":476,"class":48}]