[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pregnancy-related\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pregnancy-related":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,123,0,25,[9,42,65,94,117,140,166,191,213,243,272,300,326,349,417,448,469,491,518,546,571,599,626,650,675],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100635763","elafibranor-pregnancy-surveillance-program-a-study-to-evaluate-the-safety-of-elafibranor-during-pregnancy-100635763",false,"NCT07556913","Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy","Elafibranor Pregnancy Surveillance Program: A Post Marketing, Long Term, Multi-Center, Noninterventional, and Descriptive Study to Characterize Pregnancy and Maternal Complications and to Describe Effects on the Developing Fetus, Neonate and Infant Among Individuals Exposed to Elafibranor During Pregnancy","Inclusion Criteria:\n\n* Maternal exposure to at least one dose of elafibranor, either: Within three weeks prior to conception (based on the estimated date of LMP) or At any time during pregnancy (from the estimated date of conception through pregnancy outcome).\n* Participants who were previously enrolled in this program during a past pregnancy and who meet inclusion criteria #1 for the subsequent pregnancy are eligible to enroll again.\n* Informed consent or IRB\u002FIEC-approved waiver of informed consent (not applicable if reported by Ipsen PV according to usual pharmacovigilance practices).\n\nExclusion Criteria:\n\n* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.","FEMALE",{"count":19,"type":20},3,"ESTIMATED","33 Months","OBSERVATIONAL","The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period \\[LMP\\]).\n\nInformation will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates.\n\nThe study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow-up lasting up to 2 years, for a maximum total duration of 12 years and 9 months.\n\nThe program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required.\n\nParticipation is voluntary, and written informed consent will be obtained before enrollment.",[25],"Pregnancy Related",[27,28,29],"Rare disease","Primary Biliary Cholangitis","Pregnancy","NOT_YET_RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":20},"2026-08-15",{"date":38,"type":20},"2039-01-31",{"name":40,"class":41},"Ipsen","INDUSTRY",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100535982","odevixibat-pregnancy-and-lactation-surveillance-program-a-study-to-evaluate-the-safety-of-odevixibat-during-pregnancy-andor-lactation-100535982","NCT06258902","Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and\u002For Lactation","Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and\u002For Lactation","Inclusion Criteria:\n\n* Exposure to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and\u002For at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).\n* Informed consent or IRB-\u002FEC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)\n\nExclusion Criteria:\n\n* Refusal to provide informed consent, if required",{"count":50,"type":20},20,"10 Years","The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and\u002For at any time during lactation (up to 12 months of infant age or weaning, whichever comes first.\n\nThis study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance.\n\nStudy start date is either start of data collection or first patient enrolled whatever occurs earlier.\n\nThe surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected.\n\nNo additional laboratory tests or HCP assessments will be required as part of this surveillance program.",[25],[27,55,29,56],"PFIC","Lactation","RECRUITING",{"date":33,"type":34},{"date":60,"type":34},"2023-09-28",{"date":62,"type":20},"2032-05-31",{"name":40,"class":41},1,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":64},"100512089","real-time-continuous-glucose-monitoring-system-in-t2dm-with-pregnacy-100512089","NCT05947916","Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy","Effect of Real Time Continuous Glucose Monitoring System on Management of Women With Type 2 Diabetes Mellitus During Pregnancy in a Multidisciplinary Comprehensive System","Inclusion Criteria:\n\n* A clear history of type 2 diabetes, or a history of type 2 diabetes diagnosed in early pregnancy\n* Singleton gestation at 4-26 weeks, with substandard glycemic control (i.e., fasting glucose \\> 5.3 mmol\u002FL, and or 1 hour postprandial glucose \\> 7.8 mmol\u002FL, and or 2 hours postprandial glucose \\> 6.7 mmol\u002FL) after lifestyle intervention ± basal insulin therapy, as assessed by the endocrinology department. Patients who need insulin regimen with basal plus meal or insulin pump regimen.\n* Patients are willing and committed to establish and follow up in the obstetrics and gynecology departments of Peking University Third Hospital, Haidian District Hospital and Yanqing District Hospital during pregnancy, and are willing to provide information on obstetric examination and perinatal medical records if they are transferred to the hospital for special reasons for follow-up or delivery.\n* Voluntarily participate in the study, examine and follow up according to this project and sign informed consent.\n* Able to pass the screening period Adherence evaluation\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes, specific type of diabetes or gestational diabetes\n* Pregnancy with severe comorbidities or diabetic complications for which obstetrics does not recommend continuation of pregnancy, including but not limited to the following: proliferative retinopathy, chronic kidney disease (eGFR less than 60 mL\u002Fmin\u002F1.73± massive proteinuria), known coronary and cerebrovascular disease, autoimmune system disease and receiving exogenous glucocorticoids or immunosuppressive therapy.\n* Patients who have been hospitalized for psychiatric treatment within 6 months prior to enrollment or are still on psychiatric medications.\n* Patients who have received other interventional studies.","18 Years","40 Years",{"count":75,"type":20},240,"INTERVENTIONAL",[78],"NA","The prevalence of type 2 diabetes mellitus (T2DM) in women of childbearing age is increasing rapidly, and low glucose compliance leads to an increased risk of adverse pregnancy outcomes for mothers and infants during pregnancy in women with T2DM. Real-time continuous glucose monitoring (CGM) is an important tool for glucose monitoring and patient education, as it can continuously record blood glucose throughout the day and provide real-time feedback on high and low blood glucose levels. This is a multicenter, open-label, randomized controlled clinical study to investigate the efficacy, safety, and maternal and infant pregnancy outcomes of using real-time CGM monitoring compared with conventional self-monitoring of blood glucose (SMBG) on the basis of multidisciplinary management in pregnant women with T2DM. One hundred and twenty pregnant women with T2DM in early pregnancy who were enrolled in intensive insulin therapy were randomly divided into the real-time CGM group and the conventional SMBG group. The real-time CGM intervention group wore real-time CGM for more than 50% of the pregnancy in addition to regular SMBG; the control group only performed regular SMBG. Both groups wore Medtronic iPro 2 for 3 days in early, mid and late pregnancy, and the time in the target range of blood glucose (TIR) was recorded in a blinded manner. Primary outcome: differences in TIR between the two groups of pregnant women in early, mid, and late pregnancy. Secondary outcomes included differences in glycated hemoglobin, hypoglycemia, insulin dose before delivery, pregnancy weight gain, and maternal and infant pregnancy outcomes.",[81,25,82,83,84],"Type2diabetes","Continuous Glucose Monitoring","Time in Range","Pregnancy Outcome","2026-06-30",{"date":33,"type":34},{"date":88,"type":34},"2024-01-30",{"date":90,"type":20},"2026-12-31",{"name":92,"class":93},"Peking University Third Hospital","OTHER",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":72,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":76,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":64},"100484453","trial-of-community-based-patient-navigation-100484453","NCT05588245","Trial of Community-based Patient Navigation","A Pragmatic Trial of Integrating Community-based Patient Navigation Into the Continuum of Maternal Care for Black Women in a Safety-Net Health System: Effects on Maternal Health, Health Care, Morbidity, and Mortality","Inclusion Criteria:\n\n* A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),\n* ≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record),\n* covered by Medicaid\n* for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs\n* expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment.\n\nExclusion Criteria:\n\n* The intent to transfer care to a health system outside of metro Atlanta\n* incarceration, which would interfere with intervention provision and outcome ascertainment\n* adults unable to give consent\n* individuals who are not yet adults\n* prisoners\n* cognitively impaired individuals with impaired decision-making capacity\n* individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)",true,"ALL",{"count":104,"type":20},540,[78],"This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.",[25],"2026-06-19",{"date":110,"type":34},"2026-06-23",{"date":112,"type":34},"2024-01-25",{"date":114,"type":20},"2027-06",{"name":116,"class":93},"Emory University",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":76,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":64},"100636043","impact-of-lactation-antenatal-teaching-by-clinicians-and-healthcare-providers-100636043","NCT07560553","Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers","Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers: Randomized Control Trial","iLATCH","Inclusion Criteria:\n\n* Nulliparous mothers\n* Multiparous mothers who did not breastfeed previous children or breastfed previous children for less than 6 months\n\nExclusion Criteria:\n\n* Mothers planning to use formula\n* Multiparous mothers who previously breastfed for more than 6 months\n* Mothers with HIV\n* Mothers with a history of breast reduction surgery\n* Infants with major birth defects that may impede growth or feeding, such as cleft lip and\u002For palate, cardiac defects, and gastrointestinal defects","45 Years",{"count":127,"type":20},196,[78],"The purpose of this study is to increase the rate of exclusive breastfeeding at 6 weeks postpartum in the Inland Empire by addressing inadequate antenatal breastfeeding education for patients.",[25,131],"Breast Feeding, Exclusive","2026-06-18",{"date":110,"type":34},{"date":135,"type":34},"2026-06-16",{"date":137,"type":20},"2028-06",{"name":139,"class":93},"Loma Linda University",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":101,"sex":17,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":76,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100487272","reducing-psychological-barriers-to-prep-persistence-among-pregnant-and-postpartum-women-in-cape-town-south-africa-100487272","NCT05624931","Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa","Inclusion Criteria:\n\n* For participants across all three aims are:\n\n  * Female sex\n  * Aged 15+\n  * Pregnant and presenting antenatal care at the Gugulethu MOU\n  * HIV-negative\n  * Recent PrEP initiation (\\\u003C1 month ago) or PrEP adherence challenges, either documented (\\>2 weeks late to pick up PrEP refill) or self-reported\n  * Moderate to severe symptoms of posttraumatic stress and\u002For depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and\u002For a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjusted by 3-5 points to facilitate recruitment.\n\nExclusion Criteria:\n\n* There are no exclusion criteria with respect to parity or gravidity.\n\n  * Participants who are unable to provide informed consent or assent in English or Xhosa\n  * Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be assessed by the research assistants. They will be trained to identify delusions, hallucinations, disorganized or pressured speech, flight of ideas, and grandiosity as they speak to potential participants.\n  * Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.","15 Years",{"count":148,"type":20},118,[78],"Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and\u002For other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (\\~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.",[152,153,25,154],"Depression","Posttraumatic Stress Disorder","Medication Adherence",[156],"HIV, pregnancy, PrEP","2026-06-15",{"date":135,"type":34},{"date":160,"type":34},"2025-04-17",{"date":162,"type":20},"2027-07-30",{"name":164,"class":93},"Boston University Charles River Campus",2,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":101,"sex":102,"minAge":4,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":76,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":64},"100394876","effects-of-systematic-cervical-exam-training-on-labor-and-delivery-care-100394876","NCT04421768","Effects of Systematic Cervical Exam Training on Labor and Delivery Care","Inclusion Criteria:\n\nHealthcare providers:\n\n• physicians, midwives, and labor and delivery nurses working on the Labor and Delivery unit within the Wake Forest Baptist Birth Center\n\nPatients:\n\n• any pregnant women receiving care on the Labor and Delivery unit of Wake Forest Baptist Birth Center\n\nExclusion Criteria:\n\nHealthcare providers:\n\n• none\n\nPatients:\n\n* placenta previa\n* vasa previa\n* any other contraindication to cervical exam",{"count":173,"type":20},1125,[78],"All physicians, nurses, and nurse midwives working on Labor and Delivery will be required to complete cervical exam simulation training. Data before and after institution of the training will be compared to determine if the training leads to less cervical exams during labor and increases consistency between examiners",[177,178,25],"Delivery Problem","Cervix; Pregnancy",[180,181,182],"vaginal delivery","labor cervical exam","labor and delivery",{"date":184,"type":34},"2026-06-17",{"date":186,"type":34},"2020-07-23",{"date":188,"type":20},"2026-12",{"name":190,"class":93},"Wake Forest University Health Sciences",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":198,"targetDuration":200,"studyType":22,"phases":4,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":64},"100480440","wakix-pitolisant-pregnancy-registry-100480440","NCT05536011","WAKIX® (Pitolisant) Pregnancy Registry","WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Pregnant woman of any age\n* Consent to participate\n* Authorization for her HCP(s) to provide data to the registry\n* For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)\n* For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy\n\nExclusion Criterion:\n\n• Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)",{"count":199,"type":20},1329,"21 Months","The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.",[25,203],"Narcolepsy","2026-06-10",{"date":206,"type":34},"2026-06-12",{"date":208,"type":34},"2021-08-24",{"date":210,"type":20},"2030-06-30",{"name":212,"class":41},"Harmony Biosciences Management, Inc.",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":101,"sex":102,"minAge":72,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":76,"phases":222,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":64},"100569106","community-based-implementation-of-adapted-stac-100569106","NCT06689930","Community-based Implementation of Adapted STAC","Dissemination and Implementation of a Community-driven Approach to Improve the Health of Women, Infants, and Families: Pre-implementation Phase to Adapt Staying Healthy After Childbirth (STAC)","Inclusion Criteria (Interviews and Focus Groups):\n\n* Belong to the STAC-CAB or Lived Experience Group\n* Aged 18 or older\n\nInclusion Criteria (CBO Staff):\n\n* Staff of CBO participating in PDSA cycle\n* Aged 18 years or older\n\nInclusion Criteria (PDSA-Cycles):\n\n* Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum\n* Self-Identify as African American or Black\n* Aged 18 years or older\n* Capable of providing informed consent in English\n* Can follow M•care System use instructions in English\n* Have ownership of a functioning and reliable smartphone to upload and use the M•other App\n* Interested in preventing or managing blood pressure during pregnancy\n\nExclusion Criteria (PDSA-Cycles):\n\n* Persistent second or third trimester bleeding at time of enrollment\n* Premature rupture of membranes in the current pregnancy at time of enrollment\n* Known unrepaired maternal congenital heart disease requiring surgical correction\n* Maternal heart failure\n* Chronic kidney disease specifically requiring dialysis\n* On greater than two antihypertensive medications at time of enrollment",{"count":221,"type":20},46,[78],"This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).",[225,226,25,227],"Blood Pressure","Hypertension","Health Equity",[229,230,231,232,225,233],"Prenatal","Post Partum","Hypertensive Disorders of Pregnancy","Remote Patient Monitoring","Community-Based Participation","2026-06-09",{"date":236,"type":34},"2026-06-11",{"date":238,"type":34},"2025-05-22",{"date":240,"type":20},"2026-09",{"name":242,"class":93},"University of Wisconsin, Madison",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":76,"phases":253,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100521458","phase-3-multiple-micronutrient-supplementation-mms-vs-ifa-acceptability-crossover-trial-100521458","NCT06069856","Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial","Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania","MIFA-ACT","Inclusion Criteria:\n\n* Attending first ANC visit at the study clinic\n* Pregnant women ≤ 15 weeks of gestation\n* Aged ≥ 18 years\n* Intending to stay in the study area for the duration of study\n* Provides informed consent\n\nExclusion Criteria:\n\n* Severe anemia (defined as Hb \\\u003C8.5 g\u002FdL per Tanzania standard of care)\n* Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC\n* Concurrent participation in other nutritional supplementation trial\n* Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.",{"count":252,"type":20},130,[254],"PHASE3","This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.",[25],[258,259,260,261,262],"Acceptability","Multiple Micronutrient Supplementation","Iron","IFA","Tanzania","2026-06-03",{"date":265,"type":34},"2026-06-04",{"date":267,"type":20},"2027-06-01",{"date":269,"type":20},"2027-12",{"name":271,"class":93},"George Washington University",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":76,"phases":283,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":64},"100640006","care4mommies-in-action-a-compassion-based-intervention-100640006","NCT07611175","Care4mommies in Action: A Compassion-based Intervention","Care4mommies in Action: Promoting Maternal Psychological Adjustment in the Perinatal Period","Care4mommies","Inclusion Criteria:\n\n* being between 26 and 33 weeks into a single-fetus pregnancy,\n* being fluent in Portuguese\n\nExclusion Criteria:\n\n* currently receiving another psychological intervention","49 Years",{"count":282,"type":20},96,[78],"Becoming a mother is a life-changing event that many experience as a time of joy and affection. However, it can also be a period of great vulnerability and uncertainty with the potential to hinder the mother's well-being and bonding with the baby, and undermine the child's later emotional, social, and cognitive development. The mothers' emotional regulation skills, namely self-compassion, may be useful in protecting the mother and the mother-baby bonding, making them a valuable target of intervention during the perinatal period and a potential protective factor for mental health. Although compassion-based interventions (CBIs) have been proven effective in promoting well-being and reducing mental health difficulties across diverse populations, including the perinatal period, evidence of their impact on maternal well-being and the mother-baby bond remains limited. Thus, the research team propose to explore the acceptability, feasibility, and preliminary efficacy of a CBI during pregnancy on mothers' compassion abilities, and consequent impact on well-being and quality of mother-baby bonding at postpartum.\n\nThis pilot cluster randomised trial addresses the research question of 'Does the Care4mommies intervention work to promote mothers' compassion and higher quality of the mother-baby bonding?' Participants will be mothers enrolled in group birth preparation courses (i.e., TAU); those groups will be randomly allocated to Care4mommies plus TAU or TAU only and assessed at pre-intervention and post-intervention(prepartum), and 3-month follow-up(postpartum). At pre- and postintervention, participants will be asked to provide self-reported information on self-compassion, shame and guilt about caring, maternal-fetal attachment, fear of self-compassion, self-criticism, and mental health. At post-intervention, they will also be asked to appraise data collection procedures and the implementation feasibility of the Care4mommies; at follow-up, they will be asked to report on their bonding to their baby. Researchers expect that participants in the Care4mommies plus TAU condition will report significant gains at post-intervention and sustain them until follow-up, both in relation to the mother and in mother-baby bonding, compared to the TAU group. Also it is expected that changes in self-compassion-related variables will explain changes in mother-fetal attachment and postpartum mother-infant bonding.",[25],[287,288,289,290],"pregnancy","mother-baby bonding","Compassion focused intervention","self-compassion","2026-05-20",{"date":293,"type":34},"2026-05-28",{"date":295,"type":34},"2026-01-02",{"date":297,"type":20},"2026-12-08",{"name":299,"class":93},"Portucalense University",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":102,"minAge":308,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":76,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":64},"100560775","rigorous-evaluation-of-yes-and-know-a-fully-virtual-sexual-health-and-well-being-intervention-for-youth-100560775","NCT06581536","Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth","Rigorous Evaluation of Yes and Know, a Fully Virtual Intervention Integrating Group-based Education With Digital Tools to Improve Youth Sexual Health and Well-Being","Yes and Know","Inclusion Criteria:\n\n* Ages 14-19; and\n* English speaking.\n\nExclusion Criteria:\n\n\\- Anyone not meeting inclusion criteria.","14 Years","19 Years",{"count":311,"type":20},1200,[78],"This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.",[25,315,316],"Sexually Transmitted Diseases","Adolescent Behavior","2026-05-11",{"date":319,"type":34},"2026-05-14",{"date":321,"type":34},"2025-08-06",{"date":323,"type":20},"2027-12-31",{"name":325,"class":93},"ETR Associates",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":76,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":64},"100640412","maternal-intake-of-eggs-and-infant-neurodevelopment-100640412","NCT07583186","Maternal Intake of Eggs and Infant Neurodevelopment","MIND","Inclusion Criteria:\n\n* Pregnant females ≥18 years of age\n* 12 to 20-weeks' gestation at enrollment\n* No serious illnesses likely to confound study outcomes\n* Consuming 3 eggs\u002Fweek or less at enrollment and willing to increase consumption during the study\n* Singleton gestation\n* Available by telephone and text\n\nExclusion Criteria:\n\n* Less than 18 years at enrollment\n* Gestational age at enrollment \\\u003C12 or \\>20 weeks\n* Any serious illness likely to confound study outcomes\n* Consuming more than 3 eggs per week at enrollment\n* Unable\u002Funwilling to consume eggs until delivery or egg allergy\n* Expecting multiple infants\n* No access to telephone or text",{"count":334,"type":20},100,[78],"The fetal brain requires DHA, choline, lutein, and zeaxanthin (L\u002FZ) for development, dependent on maternal intake during pregnancy. However, many pregnant women do not meet daily requirements through diet or prenatal vitamins. Egg yolks are rich in choline, and women who consume eggs daily are more likely to meet the adequate intake of 450 mg\u002Fday. A recent study by Christifano et al. found that maternal egg and neuroprotective nutrient intake predicted neurodevelopment at 32 and 36 weeks of gestation. This study aims to determine if fetal neurodevelopment is enhanced among women who consume a prenatal diet emphasizing egg consumption (EGG) versus a healthy prenatal diet education control group (HPD). Women between 12-20 weeks' gestation will be randomized into EGG and HPD groups. The EGG group will receive education on the importance of prenatal choline and egg consumption and be encouraged to consume 10-14 eggs per week. The HPD group will receive education on a healthy prenatal diet. Both groups will be encouraged to take a DHA supplement, and dietary intake of choline, L\u002FZ, and DHA will be collected. Fetal heart rate variability will be measured at 36 weeks gestation and infant EEGs will be conducted postnatally to examine brain function. Increasing prenatal egg consumption is both economical and feasible to boost prenatal choline intake, promote offspring neurodevelopment, and guide prenatal dietary recommendations.",[25],[29,339,340],"Prenatal Nutrition","Neurodevelopment","2026-05-06",{"date":343,"type":34},"2026-05-13",{"date":345,"type":34},"2026-01-01",{"date":137,"type":20},{"name":348,"class":93},"University of Kansas Medical Center",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":101,"sex":102,"minAge":357,"maxAge":358,"enrollmentInfo":359,"targetDuration":4,"studyType":76,"phases":361,"briefSummary":362,"conditions":363,"keywords":380,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100569405","advanced-wireless-sensors-for-neonatal-care-in-the-delivery-room-100569405","NCT06693817","Advanced Wireless Sensors for Neonatal Care in the Delivery Room","Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study","AWARD","Inclusion criteria:\n\n1. Newborns ≥35 weeks (gestational age)\n2. Newborns determined to be clinically stable at delivery\n3. Newborns with no skin abnormalities\n\nExclusion criteria:\n\n1. Newborns ≤ 35 weeks (gestational age)\n2. Newborns determined to not be clinically stable at delivery\n3. Newborns with Skin abnormalities","35 Weeks","42 Weeks",{"count":360,"type":20},600,[78],"The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:\n\n1. Assess feasibility\n2. Evaluate safety\n3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.",[364,365,366,367,368,369,25,370,371,372,373,374,375,376,377,378,379],"Sudden Unexplained Infant Death","Apnea of Newborn","Newborn Morbidity","Newborn Asphyxia","Birth Outcome, Adverse","Birth Asphyxia","Newborn; Vitality","ECG Electrode Site Reaction","Infant ALL","Infant Death","Infant, Newborn, Diseases","Infant Apnea","Infant Conditions","Parents","Delivery Problem for Fetus","Delivery Complication",[381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406],"Delivery Room","Newborn","Neonatal Resuscitation","Wireless Technology","Vital Sign Monitoring","Sudden Unexplained Post-Natal Collapse","SUPC","Obstetrical Center","Obstetrics","Neonate","Birth","Birthing Center","C-Section","Vaginal Delivery","Sensors","Heart Rate (HR)","Respiratory Rate (RR)","Blood Oxygen Saturation (SpO2)","Skin Temperature (Tskin)","Pulse Rate (PR)","International","Low-Income","Middle-Income","High-Income","Golden Hour","Post-Birth","2026-05-05",{"date":409,"type":34},"2026-05-08",{"date":411,"type":34},"2025-04-08",{"date":413,"type":20},"2027-12-30",{"name":415,"class":93},"Guilherme Sant'Anna, MD",5,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":101,"sex":17,"minAge":146,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":76,"phases":428,"briefSummary":430,"conditions":431,"keywords":434,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":64},"100528235","phase-4-uncpm-22314---pregnancy-infant-and-maternal-health-outcomes-study-100528235","NCT06158126","UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study","UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi","PrIMO","Inclusion Criteria:\n\nMaternal participants:\n\n* Confirmed pregnancy by urine pregnancy test or ultrasound.\n* Aged 15 years or older\n* PrEP-eligible by Malawi local guidelines\n* Confirmed HIV-negative based on the local HIV testing algorithm\n* Hepatitis B surface antigen (HBsAg) negative\n* Weight \\>35 kg\n* Provided informed consent and expressed willingness to participate in study activities with their infants.\n\nInfant participants: Infant participants will enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise.\n\nExclusion Criteria:\n\nMaternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the screening process:\n\n* Known to be living with HIV\n* Known allergies to CAB-LA, TDF\u002F3TC or FTC\u002FTDF\n* Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.\n* Intention to leave the study site's catchment area of Bwaila before scheduled study exit.","55 Years",{"count":427,"type":20},621,[429],"PHASE4","The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC\u002FTDF or 3TC\u002FTDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:\n\n\\- Do composite adverse pregnancy events, maternal health outcomes, and\u002For infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA?\n\nWomen who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period.\n\nIn addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.",[432,433,25],"Pre-exposure Prophylaxis","HIV Prevention",[435,29,436,437,438,439,440],"PrEP","Breastfeeding","Infant health","HIV prevention","Maternal health","Eliminating mother-to-child transmission (EMTCT)","2026-05-01",{"date":407,"type":34},{"date":444,"type":34},"2024-04-17",{"date":269,"type":20},{"name":447,"class":93},"University of North Carolina, Chapel Hill",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":72,"maxAge":125,"enrollmentInfo":456,"targetDuration":458,"studyType":22,"phases":4,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":64},"100473906","physiological-based-pharmacokinetics-approach-to-medication-exposure-during-pregnancy-and-breastfeeding-100473906","NCT05450978","Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding","Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding","PBPK","Inclusion Criteria:\n\n* Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy.\n* Women with epilepsy ability to maintain a daily medical diary\n* Women with epilepsy ability to answer side effect questionnaires\n* Women with epilepsy currently being treated with lamotrigine (LTG) or levetiracetam (LEV) or oxcarbazepine (OXC)\n\nExclusion Criteria:\n\n* Women with epilepsy having history of functional seizures.\n* Women with epilepsy history of other major medical illnesses including renal or hepatic disease, progressive cerebral disease,\n* Women with epilepsy who have inability to maintain a seizure and medication daily diary\n* Women with epilepsy with present or recent history of drug or alcohol abuse, or the use of any concomitant medications that interact with the ASM they are taking (lamotrigine, levetiracetam, oxcarbazepine).",{"count":457,"type":20},60,"2 Years","This project focuses on anti-seizure medication (ASM) clearance and physiological factors determining blood concentrations in pregnant adult women with epilepsy and amounts of exposure to their unborn children and nursing infants.",[461,25],"Epilepsy",{"date":341,"type":34},{"date":464,"type":34},"2022-07-20",{"date":466,"type":20},"2028-04-01",{"name":468,"class":93},"University of Pittsburgh",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":76,"phases":478,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":489,"locationsCount":64},"100477924","the-lullaby-project-as-a-musical-intervention-for-pregnant-individuals-with-epilepsy-100477924","NCT05503290","The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy","A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy","Inclusion Criteria:\n\n* at least 18 years of age\n* currently pregnant and primiparous\n* able to provide informed consent\n* able to have internet access\n* have a confirmed diagnosis of epilepsy based on EEG or clinical evidence\n\nExclusion Criteria:\n\n* need of a language interpreter to provide informed consent and\u002For communicate with the MH-RTH musician\n* prior involvement in the Lullaby Project",{"count":477,"type":20},30,[78],"This study's proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, effects on quality of life-related to epilepsy, symptoms of depression and anxiety, perceived stress, and feelings of empowerment.",[461,25],[482,483],"Music","Empowerment","2026-04-29",{"date":341,"type":34},{"date":487,"type":34},"2023-01-23",{"date":90,"type":20},{"name":490,"class":93},"University Health Network, Toronto",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":125,"enrollmentInfo":499,"targetDuration":4,"studyType":76,"phases":501,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":165},"100472616","clinical-antenatal-randomised-study-to-characterise-key-roles-of-tetrahydrofolate-in-hypertensive-pregnancies-100472616","NCT05434195","Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies","Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies (CAREFOL-HT)","CAREFOL-HT","Inclusion Criteria (Preeclampsia individuals):\n\n* Diagnosed with preeclampsia, as defined in Section 8.1, at \\\u003C34 weeks' gestation within the last 48 hours and with no delivery planned within the next week\n* Receiving antenatal care in the John Radcliffe Hospital\n* Participant is willing and able to give informed consent for participation in the study\n* Age \\>18 and ≤45 years\n\nExclusion Criteria (Preeclampsia individuals):\n\nThe participant may not enter the study if ANY of the following apply:\n\nMaternal\n\n* History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease\n* History of preexisting chronic renal disease\n* Contraindication to taking folate related supplements\n* Folate supplementation in excess of 400mcg in the third trimester\n* Low vitamin B12 levels (\\\u003C148 pmol\u002FL)\n* Intake of either proton pump inhibitors or anti-epileptic drugs\n* Organ dysfunction Fetal\n* Any known trisomy\n* Fetus with congenital heart defect\n* Fetus at a high risk of heart disease\n* Known infection of fetus\n* Known severe anaemia\n\nInclusion Criteria (Normotensive individuals):\n\n* Participant is willing and able to give informed consent for participation in the study\n* Age \\>18 and ≤45 years\n* Normotensive, blood pressures \\\u003C140\u002F90 throughout antenatal period\n* Less than 2 moderate risk factors for hypertensive disease in pregnancy according to the NICE guideline for management of hypertension in pregnancy\n* SFlt\u002FPIGF ratio \\\u003C35\n\nExclusion Criteria (Normotensive individuals):\n\nThe participant may not enter the study if ANY of the following apply:\n\nMaternal\n\n* Diagnosis of hypertensive disorder of pregnancy\n* Use of beta blockers such as atenolol or equivalent\n* History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease\n* History of preexisting chronic renal disease Fetal\n* Any known trisomy\n* Fetus with congenital heart defect\n* Fetus at a high risk of heart disease\n* Known infection of fetus\n* Known severe anaemia",{"count":500,"type":20},128,[78],"Study background\n\nHigh blood pressure during pregnancy is a worldwide health problem that can be dangerous to mothers and commonly causes premature birth and small babies. There is also growing evidence that mothers who suffer from high blood pressure in pregnancy, and their babies, have a higher risk of high blood pressure and cardiovascular disease later in life. Previous studies have revealed detrimental changes in the structure and function of the heart and blood vessels of mothers, and their babies, who experience this common complication. These changes may explain their increased risk of later disease. The investigators have also learned through previous studies that tetrahydrobiopterin (BH4), a molecule that has a role in blood vessel health, plays an important role in stabilising blood vessel function. Lower levels of BH4 are evident in both the placenta and the umbilical cord from mothers with high blood pressure. We, therefore, want to investigate how closely BH4 levels are related to clinical features of pre-eclampsia and whether altering levels of BH4, using a nutritional supplement, improves features of the disease such as blood vessel function. To do this, the investigators need to compare the levels of BH4 between mothers with pre-eclampsia, those taking the supplement and those without pre-eclampsia. The investigators also compare how the heart and blood vessels look and function in these groups using ultrasound methods, including echocardiography and fetal sonography.\n\nStudy objectives\n\nCAREFOL-HT will assess how levels of BH4 differ in pregnant women with high blood pressure and if this is reflected in functional changes in the heart and blood vessels of these women. The investigators will also determine whether changing levels of BH4, using a tetrahydrofolate supplement (5-MTHF), changes blood vessel function.",[504,505,25],"Pre-Eclampsia","Pregnancy Induced Hypertension",[507,508,504,509],"5-methyltetrahydrofolate","Tetrahydrobiopterin","Antenatal study","2026-04-28",{"date":484,"type":34},{"date":513,"type":34},"2021-06-01",{"date":515,"type":20},"2026-10",{"name":517,"class":93},"University of Oxford",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":125,"enrollmentInfo":525,"targetDuration":4,"studyType":76,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":64},"100635118","the-effect-of-mindfulness-based-self-compassion-training-on-childbirth-fear-pregnancy-stress-and-comfort-in-primiparous-women-100635118","NCT07548528","The Effect of Mindfulness-Based Self-Compassion Training on Childbirth Fear, Pregnancy Stress, and Comfort in Primiparous Women","SelfCompassion","Inclusion Criteria:\n\n* Women aged between 18 and 45, Women who are pregnant for the first time, Women who live with their partner, Women who are 28 weeks or older in pregna\n\nExclusion Criteria:\n\n* Women with multiple pregnancies, Women with any communication disorder, Women with a diagnosed psychiatric disorder, Women who have any health problems during pregnancy (such as hypertension, gestational diabetes, etc.) will be excluded from the study.",{"count":526,"type":20},80,[78],"The purpose of this study was to determine the effects of mindfulness-based self-compassion training provided to primiparous women on fear of childbirth, pregnancy stress, and comfort.\n\nResearch Hypotheses H1a: Mindfulness-based self-compassion training provided to primiparous women reduces fear of childbirth.\n\nH1b: Mindfulness-based self-compassion training provided to primiparous women reduces pregnancy stress.\n\nH1c: Mindfulness-based self-compassion training provided to primiparous women increases comfort.",[25],[531,532,533,534,290,535,536],"fear of birth","midwife","pregnant","comfort","primiparous","stress","2026-04-21",{"date":539,"type":34},"2026-04-23",{"date":541,"type":20},"2026-04",{"date":543,"type":20},"2026-08",{"name":545,"class":93},"Inonu University",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":425,"enrollmentInfo":553,"targetDuration":4,"studyType":76,"phases":555,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":165},"100590293","nourishing-tomorrow-role-of-medically-tailored-groceries-in-addressing-food-insecurity-during-pregnancy-100590293","NCT06965530","Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy","The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships","Inclusion Criteria:\n\n* 18 years of age and older\n* Pregnant patients \\>10 weeks and \\\u003C22 weeks gestation at randomization (must be consented by 18 weeks)\n* Eligible for Medicaid\n* Singleton pregnancy, confirmed by ultrasound\n* An established patient of the UH or Metro pregnancy clinic\n* English speaking\n* Lives in Cuyahoga County, Ohio\n\nExclusion Criteria:\n\n* Under 18 years old",{"count":554,"type":20},360,[78],"Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.",[25,558,368],"Prematurity",[560,561],"Randomized trial","Behavioral intervention","2026-04-16",{"date":564,"type":34},"2026-04-20",{"date":566,"type":34},"2025-11-12",{"date":568,"type":20},"2029-05-31",{"name":570,"class":93},"Case Western Reserve University",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":101,"sex":17,"minAge":579,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":76,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":64},"100476505","accountability-for-care-through-undoing-racism--equity-for-moms-100476505","NCT05484804","Accountability for Care Through Undoing Racism & Equity for Moms","Reducing Racial Disparities in Maternal Care Through Data-Based Accountability and Doula Support","ACURE4Moms","Inclusion Criteria:\n\nPractices:\n\n* Have at least 180 Black patient deliver over 2 years\n* Be willing to be randomized\n* Be willing to adhere to the study protocol\n\nPatient survey participants:\n\n* Start prenatal care at one of the study clinics during study implementation\n* Self-identify as Black or African American\n* Able to give consent and complete surveys and interviews in English\n\nPractice staff member participants:\n\n* Employed as either a provider, nurse\u002Fmedical assistant, or office administrator at one of the clinics in this study\n\nDoula participants:\n\n* Provide doula care to patients at one the clinics in this study\n\nExclusion Criteria:\n\nPractices:\n\n* Already integrated with Community-Based Doulas\n* Already have an Early Warning System or Disparities Dashboard","12 Years","99 Years",{"count":582,"type":20},60000,[78],"This project-also known as \"Accountability for Care through Undoing Racism \\& Equity for Moms\" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 39 prenatal practices across North Carolina. Practices have been randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for \\~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.",[25,586,587,588,589,590],"Maternal Health","Maternal Mortality","Low Birthweight","Racism","Implicit Bias","2026-04-13",{"date":593,"type":34},"2026-04-17",{"date":595,"type":34},"2023-06-05",{"date":597,"type":20},"2027-08-31",{"name":447,"class":93},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":607,"enrollmentInfo":608,"targetDuration":4,"studyType":76,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":624,"locationsCount":64},"100561521","membrane-stripping-for-cervical-ripening-100561521","NCT06591247","Membrane Stripping for Cervical Ripening","Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study","Stripping","Inclusion Criteria:\n\n* Patients aged 18 and above\n* Patients with a cervical dilation of at least 1 cm\n* Full-term pregnancy\n* Cephalic presentation\n* No contraindication to vaginal delivery\n\nExclusion Criteria:\n\n* Patients with rupture of membranes\n* Patients who do not require cervical ripening and proceed directly to the delivery room for induction with oxytocin\n* Patients for whom the use of a double-balloon catheter\u002FPGE2 is contraindicated\n* Twin pregnancies\n* Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated\n* Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress","50 Years",{"count":609,"type":20},400,[78],"The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction.\n\nThe study population consists of women undergoing labor induction.\n\nThe main questions it aims to answer are:\n\n1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening?\n2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.",[613,614,615,616,25,617],"Labor, Induced","Cervical Ripening","Balloon Induction","Membrane Stripping","Induction of Birth","2026-04-10",{"date":620,"type":34},"2026-04-15",{"date":622,"type":34},"2024-08-07",{"date":323,"type":20},{"name":625,"class":93},"Meir Medical Center",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":633,"maxAge":634,"enrollmentInfo":635,"targetDuration":4,"studyType":76,"phases":636,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":64},"100537934","telehealth-diaphragmatic-vs-pelvic-exercise-in-postpartum-pregnancy-related-pelvic-girdle-pain-100537934","NCT06284278","Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain","Comparison of Diaphragmatic Breathing Exercise and Pelvic Stabilization Exercise in Postpartum Women With Pregnancy-related Pelvic Girdle Pain: A Real-time Telehealth-based Intervention","Inclusion Criteria:\n\n* Age between 20-65 years\n* Postpartum ≥ 3 months\n* Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold)\n* Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause)\n* At least 2 positive findings of 6 pain provocation tests for pelvic pain\n* Score of Active Straight Leg Rise (ASLR) test \\> 0\n\nExclusion Criteria:\n\n* being pregnant or actively trying to get pregnant\n* having known causes of pelvic girdle pain, such as fractures and rheumatism\n* having undergone lumbar, pelvic, gynecologic or obstetric surgery\n* having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy\n* having cancer\n* having cardiovascular disease\n* being diagnosed as having a psychiatric disease\n* active infection or infectious disease in the pelvis or abdomen\n* having experience with structured and supervised core or trunk exercise training programs.","20 Years","65 Years",{"count":457,"type":20},[78],"The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.",[639,25,640],"Postpartum","Pelvic Girdle Pain","2026-04-06",{"date":643,"type":34},"2026-04-08",{"date":645,"type":34},"2024-03-01",{"date":647,"type":20},"2026-07-31",{"name":649,"class":93},"YI-JU TSAI",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":72,"maxAge":425,"enrollmentInfo":657,"targetDuration":4,"studyType":76,"phases":659,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":64},"100632812","maternal-and-fetal-electrocardiograms-separation-algorithm-100632812","NCT07518550","Maternal and Fetal Electrocardiograms Separation Algorithm","The Development and Validation of Maternal and Fetal Electrocardiograms (ECG) Separation Algorithm Based on Artificial Intelligence Application","Inclusion Criteria:\n\n* Age over 18 years\n* Recordings obtained during the second or third trimester of pregnancy\n* Recording duration of at least 5 minutes\n* Singleton pregnancy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age under 18 years;\n* Multiple pregnancy;\n* Recent medical procedures or interventions that could affect the quality of electrocardiographic data;\n* Severe maternal conditions (e.g., severe eclampsia, shock, severe organ failure, etc.);\n* Severe fetal conditions (e.g., significant hypoxia, severe placental-fetal syndrome, and other life-threatening states).\n\nExclusion criteria:\n\n1\\. Patient's refusal to continue participation in the study.",{"count":658,"type":20},350,[78],"Effective monitoring of fetal heart activity during the second and third trimesters remains a vital challenge in perinatal medicine. This study proposes an adaptive algorithm for extracting the fetal electrocardiograms signal from abdominal ECG in pregnant women, considering the physiological characteristics of each trimester. Utilizing modern machine learning methods, independent component analysis, and data from wearable textile electrodes. The goal is to enhance the accuracy and reliability of automatic signal separation. A dataset of 300 recordings will be collected and analyzed. The resulting algorithm will enable rapid and precise detection of fetal heartbeats. To validate the algorithm, 50 patients will be recruited separately.",[25],[287,663,664,665,666],"maternal and fetal electrocardiograms separation","2-3 trimester","abdominal ECG signals","artificial intelligence","2026-04-02",{"date":643,"type":34},{"date":670,"type":34},"2026-02-12",{"date":672,"type":20},"2028-05-30",{"name":674,"class":93},"I.M. Sechenov First Moscow State Medical University",{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":4,"eligibilityCriteria":681,"healthyVolunteers":101,"sex":17,"minAge":72,"maxAge":125,"enrollmentInfo":682,"targetDuration":4,"studyType":76,"phases":684,"briefSummary":685,"conditions":686,"keywords":688,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":64},"100632735","sexual-health-education-during-pregnancy-100632735","NCT07517549","Sexual Health Education During Pregnancy","The Effect Of Sexual Counseling Based On the Extended Plissit Model On Sexual Function, Marital Adjustment, Sexual Quality Of Life, Depression, Anxiety, And Stress During Pregnancy And Postpartum","Eligibility criteria;\n\n* Volunteers to participate in the research,\n* primary school graduate,\n* Pregnant between 16-20 weeks\n* Having a single pregnancy,\n* Able to understand and speak Turkish,\n* Living with his wife for the past four weeks,\n* No threat of abortion or premature birth,\n\nExclusion Criteria:\n\n* Someone who has been diagnosed with a chronic illness,\n* People with diagnosed physical and mental health issues,\n* Someone who has been diagnosed with a psychological disorder,\n* Having a high-risk pregnancy,\n* Having an IVF pregnancy,\n* Low threat,\n* Anyone who has been diagnosed with any sexually transmitted disease, either themselves or in their partner,\n* Those using medications that may negatively affect sexual function,\n* including antipsychotics, antihypertensives, phenobarbital, and opioids.",{"count":683,"type":20},70,[78],"This experimental, randomized controlled, single-blind study includes intervention and control groups. Pregnant women between 16 and 20 weeks of gestation who meet the inclusion criteria and agree to participate will be included in the study. Pregnant women will be randomly assigned to groups. Pre-test data will be collected from both groups. The intervention group will receive sexual counseling training in two sessions, face-to-face and in groups, until week 22. Second test data will be collected after week 37 (before delivery), and final test data will be collected three months after delivery. This study is expected to have a significant impact on women's lives, as this topic is considered taboo in our country, leading to a lack of open discussion and the prevalence of misconceptions and false beliefs (sexual myths).",[687,152,25],"Sexuality",[687,29,689],"Anxiety","2026-04-01",{"date":643,"type":34},{"date":693,"type":34},"2026-03-15",{"date":695,"type":20},"2026-11-30",{"name":697,"class":93},"Ordu University"]