[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pregnancy-high-risk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pregnancy-high-risk":495},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,50,80,105,131,159,184,216,242,270,299,320,346,371,392,418,441,459,482],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100550351","phase-4-decide-a-comparative-effectiveness-trial-of-metformin-versus-insulin-for-the-treatment-of-gestational-diabetes-100550351",false,"NCT06445946","DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes","DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes","DECIDE","Inclusion Criteria:\n\n* Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.\n* Age 18 years or older\n* Gestational age at randomization between 20 0\u002F7 - 33 6\u002F7 weeks based on project gestational age.\n* GDM diagnosis less than or equal to 33 6\u002F7 weeks based on project gestational age.\n* Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) prior to randomization per determination of the provider or documented in the medical record.\n* Patient willingness and ability to attend 2-year follow-up visit.\n\nExclusion criteria:\n\n* Renal disease (serum creatinine \\>1.3 mg\u002FdL) due to the potential impact of metformin on renal function.\n* Major structural malformation of the fetus.\n* Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.\n* Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and\u002For anaphylaxis.\n* For individuals with GDM diagnosed \\\u003C20 0\u002F7 weeks, documented A1c ≥\\>6.5% within prior 6 months.\n* Pregestational diabetes documented in the medical record or prior A1c\\>= 6.5%\n* Fasting hyperglycemia \\>115 mg\u002Fdl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).\n* Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).\n* Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.\n* Language barrier (appropriate translation resources unavailable at the site)\n* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.","FEMALE","18 Years",{"count":20,"type":21},1572,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.\n\nThis study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.",[27,28],"Gestational Diabetes Mellitus","Pregnancy, High Risk",[30,31,32,33,34,35,36],"Insulin","Pregnancy","Glycemic control","Metformin","Gestational diabetes","Diabetes","Adverse pregnancy outcomes","RECRUITING","2026-06-24",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":41},"2024-08-01",{"date":45,"type":21},"2030-12",{"name":47,"class":48},"Ohio State University","OTHER",24,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100490156","successfully-achieving-and-maintaining-euglycemia-during-pregnancy-for-type-2-diabetes-through-technology-and-coaching-100490156","NCT05662462","Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching","ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching","Inclusion Criteria:\n\n1. pregnant individuals age ≥18 years;\n2. ≤20 weeks of gestation (specifically, \\\u003C20+6 weeks);\n3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;\n4. Medicaid insurance;\n5. English or Spanish speaking;\n6. cognitively able to complete the study requirements;\n7. consent to all study activities;\n8. accessible for participation in study activities;\n9. use a smartphone with internet access;\n\nParticipants must also consent to the study team abstracting information from their electronic health records (EHRs), using CGM for glucose monitoring if randomized to the intervention group, tracking the participants' clinic, hospital, and emergency room visits during the study period, as well as tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application (app), including what activities are used in the mobile application (e.g., recording blood glucose, scheduling appointments, messaging their healthcare providers, accessing educational resources).",{"count":58,"type":21},124,[60],"NA","The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \\\u003C6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \\\u003C6.5% in the third trimester compared to the standard care group",[63,64,65,28],"Pre-Gestational Diabetes","Type2diabetes","Pregnancy in Diabetic",[67,31,68,69,70,71,32],"mHealth","Type 2 diabetes","Continuous glucose monitoring","Mobile application","Medicaid",{"date":73,"type":41},"2026-06-29",{"date":75,"type":41},"2024-07-11",{"date":77,"type":21},"2029-03",{"name":47,"class":48},1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100448849","intensive-glycemic-targets-in-overweight-and-obese-women-with-gestational-diabetes-100448849","NCT05124808","Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes","Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial","iGDM","Inclusion Criteria:\n\n* Pregnant women between the ages of 18-45\n* Singleton gestation\n* Gestational age between 12 0\u002F7-32 6\u002F7 weeks' gestation with gestational diabetes diagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg\u002FdL or two or more abnormal values on a 100g OGTT using the Carpenter-Coustan Criteria\n* Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg\u002Fm2 or ≥23 kg\u002Fm2 in Asian Americans)\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Inability to communicate with members of the study team, despite the presence of an interpreter\n* Planned delivery at a non-study affiliated hospital\n* Known renal disease with a baseline creatinine \\>1.5 mg\u002FdL\n* Significant fetal anomalies diagnosed prior to study enrollment (these will include anomalies such as gastroschisis, spina bifida, complex congenital heart disease, or serious karyotypic anomalies that may lead to early delivery or increased risk of neonatal death)\n* Oral or IV\u002FIM steroid use within 7 days of study enrollment","45 Years",{"count":90,"type":21},828,[60],"This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.",[94,28,95],"Gestational Diabetes","Overweight and Obesity","2026-06-22",{"date":38,"type":41},{"date":99,"type":41},"2022-03-01",{"date":101,"type":21},"2026-12-31",{"name":103,"class":48},"Indiana University",5,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":79},"100636063","nourish---a-healthcare-community-partnership-to-improve-nutrition-for-optimal-glycemic-control-and-pregnancy-outcomes-with-pregestational-diabetes-100636063","NCT07560813","NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes","NOURISH","Inclusion criteria:\n\n* Pregnant with singleton or twin pregnancy\n* Gestational age \\>8+0 to ≤22+6 weeks at enrollment by project EDD\n* Age ≥ 18 years.\n* Type 1 or 2 diabetes.\n* Screen positive for food insecurity based on answering \"Often\" or \"Sometimes\" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).\n* English or Spanish speaking.\n* Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.\n* Hemoglobin A1c criteria:\n\n  * If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.\n  * If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.\n\nExclusion Criteria\n\n* Involuntarily confined or detained.\n* Considered as having a diminished decision-making capacity.",{"count":113,"type":21},174,[60],"Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.",[117,118,28],"Type 2 Diabetes","Type 1 Diabetes",[31,118,117,120,121,122],"food insecurity","nutrition insecurity","social determinants of health","NOT_YET_RECRUITING","2026-06-17",{"date":96,"type":41},{"date":127,"type":21},"2026-07-01",{"date":129,"type":21},"2030-06-30",{"name":47,"class":48},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":17,"minAge":140,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":104},"100508724","prisma-maternal-and-newborn-health-study-100508724","NCT05904145","PRISMA Maternal and Newborn Health Study","Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health","PRiSMA-MNH","A woman who meets the following inclusion criteria during screening may be enrolled:\n\n* Lives within the study catchment area;\n* Meets minimum age requirement in study site country:\n\n  * Ghana: 15 years of age;\n  * Kenya: 18 years of age or those who meet the criteria of emancipated minors;\n  * Pakistan: 15 years of age or those who meet the criteria of emancipated minors;\n  * Zambia: 15 years of age;\n  * India: 18 years of age\n* Intrauterine pregnancy \\\u003C20 weeks gestation verified via ultrasound;\n* Provides informed consent.\n\nA woman who meets the following exclusion criteria during screening may NOT be enrolled:\n\n* Nonviable (e.g. ectopic or molar) pregnancy;\n* Plans to relocate outside of the study catchment area during pregnancy and\u002For postpartum.",true,"15 Years",{"count":142,"type":21},267897,"OBSERVATIONAL","Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.\n\nAdditionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.\n\nThe Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.",[28],[147,148,149],"Antenatal Care (ANC)","Postnatal Care (PNC)","Maternal Newborn Health","2026-06-09",{"date":152,"type":41},"2026-06-11",{"date":154,"type":41},"2022-08-01",{"date":156,"type":21},"2028-12-31",{"name":158,"class":48},"George Washington University",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":79},"100615523","phase-4-permissive-versus-strict-intrapartum-glucose-management-in-type-1-diabetes-prism-t1d-100615523","NCT07293715","Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)","PRISM-T1D","Inclusion Criteria\n\n* Pregnant individuals\n* ≥ 18 years old\n* Type 1 diabetes\n* Intention for vaginal delivery and admitted to Labor and Delivery\n* Singleton, non-anomalous fetus\n* Gestational age greater than or equal to 35 weeks gestation.\n* Cervical dilation is less than 6 cm.\n* Delivering at the study institution\n\nExclusion criteria:\n\n* Scheduled cesarean delivery\n* Cervical dilation ≥ 6 cm on presentation to L\\&D\n* Receipt of antenatal corticosteroids within 7 days of randomization\n* Fetal demise\n* Major fetal anomaly (attached)\n* Multiple gestation\n* Non-English speaking",{"count":167,"type":21},44,[24],"PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg\u002FdL) or strict (70-110 mg\u002FdL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.",[28,118],[31,172,118,173,174,175],"Continuous Glucose Monitor","Automated insulin delivery","Hybrid closed loop","Insulin pump","2026-04-28",{"date":178,"type":41},"2026-04-29",{"date":180,"type":41},"2026-02-25",{"date":182,"type":21},"2027-06",{"name":47,"class":48},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":195,"conditions":196,"keywords":202,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":79},"100634507","mocha-embedded-inpatient-mental-health-care-for-high-risk-perinatal-patients-100634507","NCT07540585","MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients","MOCHA Protocol: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients","MOCHA","Inclusion Criteria:\n\n* 18 years old or older\n* Pregnant (or recently have given birth) at any gestational age\n* Must have experienced at least one adverse pregnancy outcome\n* Admitted for an extended inpatient stay\n* English speaking\n\nExclusion Criteria:\n\n* Under 18 years old\n* Not currently pregnant or past one year postpartum\n* Not experienced at least one adverse pregnancy outcome\n* Not admitted for an extended inpatient stay at RMT","100 Years",{"count":194,"type":21},50,"Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited. Project MOCHA integrates early mental health screening, trauma-informed psychotherapy, and structured follow-up into routine inpatient maternity care for individuals at elevated clinical risk.\n\nThis single-arm implementation study examines the feasibility, acceptability, and fidelity of delivering a Collaborative Mental Health Care Program within a high-risk obstetric inpatient setting. The program includes brief inpatient psychotherapy, symptom monitoring, and post-discharge follow-up over three months. Preliminary changes in depression, anxiety, attention-deficit hyperactivity disorder, and posttraumatic stress symptoms will be assessed to inform future effectiveness trials and broader health system integration.",[197,198,28,199,200,201],"Anxiety Disorders","Stress Disorders, Post-Traumatic","Depressive Disorder, Major","Pregnancy Complications","ADHD - Attention Deficit Disorder With Hyperactivity",[203,204,190,205,206,207],"Collaborative Mental Health Care Program","Inpatient high-risk pregnancy support","High-risk pregnancy mental health","Perinatal psychotherapy","Trauma-informed therapy","2026-04-18",{"date":210,"type":41},"2026-04-22",{"date":212,"type":21},"2026-06-01",{"date":214,"type":21},"2027-06-01",{"name":103,"class":48},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":79},"100469118","early-detection-of-gestational-diabetes-mellitus-in-pregnancy-100469118","NCT05388643","Early Detection of Gestational Diabetes Mellitus in Pregnancy","Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial","Inclusion Criteria:\n\n* 1\\) age greater than or equal to 18 years old,\n* 2\\) singleton gestation less than or equal to 12 weeks at initial obstetric visit,\n* 3\\) receiving prenatal care at UMMHC and plans to deliver at UMMHC,\n* 4\\) able and willing to provide informed consent,\n* 5\\) English or Spanish speaking, and\n* 6\\) are at high risk for developing GDM by ACOG clinical risk factor guidelines.\n\nExclusion Criteria:\n\n* 1\\) known diagnosis of pre-existing pregestational diabetes,\n* 2\\) plan to receive prenatal care or deliver outside of UMMHC,\n* 3\\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or\n* 4\\) systemic steroid use.",{"count":224,"type":21},80,[60],"The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).",[228,28],"Gestational Diabetes Mellitus in Pregnancy",[31,94,230,231,232],"Screening","Maternal Outcomes","Neonatal Outcomes","2026-03-31",{"date":235,"type":41},"2026-04-06",{"date":237,"type":41},"2025-07-01",{"date":239,"type":21},"2026-12-01",{"name":241,"class":48},"University of Massachusetts, Worcester",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"100546525","phase-4-improvement-of-pprom-management-with-prophylactic-antimicrobial-therapy-iprompt-100546525","NCT06396078","Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)","Improvement of PPROM Management With Prophylactic Antimicrobial Therapy","Inclusion criteria\n\n* Admitted to the inpatient unit for expectant management of PPROM until delivery\n* Age ≥ 18 years with the ability to provide informed consent\n* Gestational age between 23 0\u002F7 and 32 6\u002F7 weeks\n\nExclusion criteria\n\n* Having received more than one dose of any prophylactic antibiotic\n* Suspected or confirmed infection requiring treatment with antibiotics\n* Allergy or contraindication to an antibiotic in either arm\n* Maternal immunosuppression",{"count":250,"type":21},56,[24],"To conduct an unblinded pragmatic randomized controlled trial (pRCT) \"Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)\" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin\u002Famoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \\\u003C34 weeks.",[254,28,255],"Preterm Premature Rupture of Membrane","Preterm Birth",[31,257,258,259,260],"Preterm premature rupture of membranes","Latency","Chorioamnionitis","Antibiotic prophylaxis","2026-01-23",{"date":263,"type":41},"2026-01-27",{"date":265,"type":41},"2024-07-18",{"date":267,"type":21},"2026-12",{"name":47,"class":48},2,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":79},"100509101","a-randomized-controlled-trial-of-diabetes-screening-immediately-postpartum-dip-and-follow-up-pp-care-100509101","NCT05909046","A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE","A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) - Follow up Study: Patient Perspectives on Postpartum Interventions to Improve Future Maternal CARdiovascular hEalth After Gestational Diabetes (PP CARE)","DIP - Inclusion Criteria:\n\n* Immediately postpartum individuals during their delivery hospital admission\n* ≥ 18 years old with the ability to give informed consent.\n* Diagnosed with GDM during pregnancy by:\n\n  * Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR\n  * Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis\n* English or Spanish speaking\n* Receiving prenatal and postpartum care at OSU\n\nDIP- Exclusion Criteria:\n\n* Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)\n* Not English or Spanish speaking\n\nPP CARE Inclusion criteria: Enrolled DIP participants who are English speaking will be eligible for PP CARE follow up if they are between 12 and 24 months postpartum.\n\nPP CARE Exclusion criteria: Spanish speaking DIP participants will be excluded because the study team does not include anyone who is Spanish speaking.",{"count":278,"type":21},104,[60],"DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.\n\nFollow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions",[63,64,65,28,94,282],"Gestational Diabetes Mellitus in the Puerperium",[284,31,285,286,287,288,289,290],"2-hour oral glucose tolerance test (OGTT)","diabetes mellitus screening","postpartum","cardiometabolic health","cardiovascular health","type 2 diabetes","prediabetes","2025-11-19",{"date":293,"type":41},"2025-11-24",{"date":295,"type":41},"2023-07-24",{"date":297,"type":21},"2026-06-30",{"name":47,"class":48},{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":79},"100428595","phase-4-anticoagulation-profile-in-pregnant-women-treated-with-three-times-a-day-of-low-molecular-weight-heparin-lmwh-100428595","NCT04861103","Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)","Inclusion Criteria:\n\n* Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.\n* Participants must be age 18 or older.\n\nExclusion Criteria:\n\n* Women with multiples.\n* Women less than age 18\n* History of Heparin Induced Thrombocytopenia (HIT)\n* Allergy to enoxaparin",{"count":306,"type":21},12,[24],"Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.",[28,310],"Anticoagulants","2025-10-27",{"date":313,"type":41},"2025-10-29",{"date":315,"type":41},"2020-10-01",{"date":317,"type":21},"2027-07-31",{"name":319,"class":48},"University of California, Irvine",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":344,"locationsCount":79},"100499976","phase-3-transdermal-patch-for-buprenorphine-induction-during-pregnancy-patch-bridge-100499976","NCT05790252","Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)","Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)","Patch BRIDGE","Inclusion Criteria:\n\n* Viable pregnancy\n* Meet diagnostic criteria for opioid use disorder\n* Receive prenatal care through opioid use disorder specific clinic at our institution\n* Opioid use within 24 hours prior to presentation\n* Desire treatment with buprenorphine\n\nExclusion Criteria:\n\n* Patients already receiving treatment for opioid use disorder\n* History of prior induction attempt with buprenorphine\n* Active withdrawal at time of presentation\n* Medical contraindication to buprenorphine\n* Requiring immediate hospitalization","110 Years",{"count":330,"type":21},40,[332],"PHASE3","The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:\n\n1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?\n2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.",[335,336,28,200,337],"Opioid Use Disorder","Pregnancy Related","Buprenorphine Withdrawal","2025-10-10",{"date":340,"type":41},"2025-10-14",{"date":342,"type":41},"2023-11-27",{"date":239,"type":21},{"name":345,"class":48},"Washington University School of Medicine",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":354,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":269},"100607561","relationship-of-dv-doppler-parameters-to-perinatal-outcomes-in-iugr-vs-non-iugr-100607561","NCT07190157","Relationship of DV Doppler Parameters to Perinatal Outcomes in IUGR vs Non-IUGR","Evaluation of the Relationship Between Ductus Venosus Doppler Parameters and Perinatal Outcomes in Pregnancies With and Without Intrauterine Growth Restriction","DV-FGR","Inclusion Criteria:\n\n* Singleton pregnancies between 24 and 37 weeks of gestation Singleton pregnancies with abdominal circumference (AC) and\u002For estimated fetal weight (EFW) below the 10th percentile for gestational age Singleton pregnancies with abdominal circumference (AC) and\u002For estimated fetal weight (EFW) between the 10th and 90th percentiles for gestational age\n\nExclusion Criteria:\n\nMultiple pregnancies Pregnancies with major fetal structural anomalies or chromosomal abnormalities Pregnant women with maternal systemic comorbidities (e.g., diabetes mellitus, chronic hypertension, renal disease, autoimmune disorders) Pregnancies in women under 18 years of age Presence of perinatal infection Pregnancies conceived by in vitro fertilization (IVF)\n\n\\-",{"count":355,"type":21},160,"This observational study investigates whether blood flow in the ductus venosus, a small fetal vein measured by Doppler ultrasound, is related to pregnancy outcomes. A total of pregnant women with and without intrauterine growth restriction (IUGR) will be examined between 24 and 37 weeks of gestation. Ductus venosus Doppler parameters will be recorded and compared with perinatal outcomes such as Apgar scores, neonatal intensive care unit admission, and perinatal mortality. The aim of this research is to improve the early identification of high-risk pregnancies and to support better monitoring and management strategies for fetal health.",[358,359,28],"Fetal Growth Restriction","Perinatal Outcome",[359,358,31],"2025-09-30",{"date":363,"type":41},"2025-10-02",{"date":365,"type":21},"2025-10-01",{"date":367,"type":21},"2025-11-30",{"name":369,"class":370},"Izmir City Hospital","OTHER_GOV",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":79},"100463660","continuous-glucose-monitor-use-in-pregnancy-100463660","NCT05317585","Continuous Glucose Monitor Use in Pregnancy","Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:\n\n* 1\\) age greater than or equal to 18 years old\n* 2\\) singleton gestation less than or equal to 14 weeks at initial obstetric visit\n* 3\\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg\u002FdL, or fasting plasma glucose ≥126 mg\u002FdL\n* 4\\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC\n* 5\\) able and willing to provide informed consent\n\nExclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:\n\n* 1\\) known diagnosis of type 1 diabetes or gestational diabetes\n* 2\\) plan to receive prenatal care or delivery outside of UMMHC\n* 3\\) inability to provide informed consent\n* 4\\) multifetal gestation",{"count":379,"type":21},180,[60],"The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.",[383,28],"Type 2 Diabetes Treated With Insulin",[68,31],"2025-09-29",{"date":365,"type":41},{"date":388,"type":41},"2024-05-23",{"date":390,"type":21},"2027-07-01",{"name":241,"class":48},{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":398,"maxAge":4,"enrollmentInfo":399,"targetDuration":401,"studyType":143,"phases":4,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":79},"100496047","relugolix-pregnancy-registry-an-observational-study-of-the-safety-of-relugolix-containing-therapy-exposure-in-pregnant-women-and-their-offspring-100496047","NCT05739123","Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Woman of any age\n* Currently or recently pregnant\n* Consent to participate\n* Authorization for her HCP(s) to provide data to the registry\n\nCohort 1\n\n* Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy\n\nCohort 2\n\n* Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy\n\nExclusion Criteria:\n\nThe following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)\n* Exposure to known teratogens and\u002For investigational medications during pregnancy\n* Lost to follow-up","0 Years",{"count":400,"type":21},728,"12 Months","The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.",[336,200,28],[405,406,407,31],"Relugolix","Uterine Fibroids","Endometriosis","2025-08-14",{"date":410,"type":41},"2025-08-19",{"date":412,"type":41},"2023-05-08",{"date":414,"type":21},"2033-05",{"name":416,"class":417},"Sumitomo Pharma Switzerland GmbH","INDUSTRY",{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":424,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":79},"100499667","patients-pregnant-women-with-or-without-primary-antiphospholipid-antibody-syndrome-100499667","NCT05786235","Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome","Inclusion Criteria:\n\n* Group 1\n\n  1. Pregnant patients between the ages of 18 and 45 years.\n  2. Diagnosis of primary APS, according to international classification criteria.\n* Group 2\n\n  1. Pregnant patients between the ages of 18 and 45 years.\n  2. Patients with at least one previous full-term pregnancy.\n  3. No diagnosis of APS, according to international classification criteria.\n\nExclusion Criteria:\n\n* Group 1\n\n  1. PMA pregnancies.\n  2. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology\n  3. Previous thrombotic event\n  4. Chronic renal failure not related to AD\n  5. Previous history of oncology\n* Group 2\n\n  1. Pregnancy by PMA.\n  2. Previous history of polyabortion and\u002For late pregnancy complications.\n  3. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology\n  4. Previous thrombotic event\n  5. Previous history of oncology",{"count":425,"type":21},60,"The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.\n\nTo construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1\u002FPlGF ratio during the trimesters of gestation (I TM, II TM and III TM).\n\nFor this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.",[428,429,430,200,28,431],"Preeclampsia","Immunologic Disease","Antiphospholipid Antibody Syndrome Primary","Rheumatic Diseases","2025-06-17",{"date":434,"type":41},"2025-06-18",{"date":436,"type":41},"2022-12-06",{"date":438,"type":21},"2026-06-06",{"name":440,"class":48},"IRCCS San Raffaele",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":448,"enrollmentInfo":449,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":458,"locationsCount":79},"100501284","medically-assisted-fertilization-techniques-in-systemic-immunoreumatologic-diseases-100501284","NCT05807256","Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases","Assessment of Maternal-fetal Outcome in Pregnancy From Medically Assisted Fertilization Techniques in Women With Systemic Immunoreumatologic Diseases","Inclusion Criteria:\n\n* Patients diagnosed with systemic immunoreumatologic disease such as SLE, APS, RA, SpA, SclS, SS, PM-DM, vasculitis\n* patients who have performed one or more PMAs between January 2000 and April 2021\n* patients who had their last follow-up by February 2022\n\nExclusion Criteria:\n\n* Patients diagnosed with only one organ autoimmunity (e.g., diabetes mellitus I, thyroiditis of Hashimoto's, celiac disease or chronic inflammatory bowel disease in the absence of systemic disease associated);\n* patients with severe renal failure, significant pulmonary hypertension or cardiomyopathy severe.","50 Years",{"count":450,"type":21},500,"Systemic rheumatological diseases often occur in young women of childbearing age and can therefore impact fertility. There are diseases, such as arthritis, which present no contraindication to assisted reproductive techniques (ARTs), because there is no influence on the disease itself if the disease activity at conception is stable. On the other hand, patients suffering from connective tissue diseases, primarily Systemic Lupus Erythematosus (SLE) and patients suffering from primary or SLE-related Anti-Phospholipid Antibody Syndrome (APS), deserve more targeted therapies both in the context of ARTs and in the ensuing pregnancy.\n\nTo evaluate the response to ARTs in patients with systemic rheumatological diseases, both in terms of reactivation of the underlying pathology and in terms of ARTs outcome.",[431,453,28,200,429],"Fertility Disorders",{"date":434,"type":41},{"date":456,"type":41},"2022-05-04",{"date":367,"type":21},{"name":440,"class":48},{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":469,"studyType":143,"phases":4,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":79},"100566402","commercial-or-open-source-closed-loop-impact-on-pregnancy-study-100566402","NCT06654713","Commercial or Open Source Closed Loop Impact on Pregnancy Study","Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study","COSCLIP","Inclusion criteria:\n\n* Pregnant\n* Diagnosis of type 1 diabetes (T1D) prior to pregnancy\n* Active use of automated insulin delivery (AID) system\n\nExclusion criteria:\n\n* Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)",{"count":468,"type":21},1000,"1 Year","The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:\n\n* What are the maternal and neonatal outcomes with AID system use in pregnancy?\n* What are the glycemic outcomes with AID system use in pregnancy?\n* What are the behavioral and emotional outcomes with AID system use in pregnancy?\n\nResearchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.\n\nParticipants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.",[118,28,472,336],"Insulin Dependent Diabetes","2025-05-06",{"date":475,"type":41},"2025-05-07",{"date":477,"type":41},"2025-03-13",{"date":479,"type":21},"2029-12-31",{"name":481,"class":48},"University of California, San Francisco",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":491,"conditions":492,"keywords":496,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":514},"100589815","t1d-pregnancy--me-100589815","NCT06959316","T1D Pregnancy & Me","Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology","PRAM-T1D","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Clinical diagnosis of presumed T1D for at least 6 months duration\n3. Less than 15 weeks gestation at time of enrollment based on due date from provider\n4. Planned CGM use on a regular basis (e.g., ≥10 out of 14 days) and willing to continue using CGM regularly with no plans to discontinue CGM use during the study\n5. Following intensive insulin therapy regimen defined as basal-bolus delivery via an insulin pump (including a closed loop system) or multiple daily injections (MDI)\n6. Have access to technology that may be required to complete study questionnaires and share diabetes device data.\n7. Resident of the United States and plans to reside in the U.S. for the duration of the study\n8. Comprehends written and spoken English or Spanish\n9. Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol\n\nExclusion Criteria:\n\n1. Multiple pregnancy\n2. Current renal dialysis or plan to begin renal dialysis during the study\n3. History of liver cirrhosis\n4. Active cancer treatment with systemic chemotherapy\n5. Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy\n6. Prior participation in this study",{"count":450,"type":21},"T1D Pregnancy \\& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.",[493,494,495,472],"Diabetes Mellitus, Type 1","Pregnancy in Diabetics","Pregnancy, High-Risk",[497,498,31,175,499,500,501,502,503,504,174,505],"Type 1 diabetes","Pregnant","Continuous glucose monitor","Remote study","Online study","T1D","CGM","Insulin injection","HCL","2025-04-28",{"date":473,"type":41},{"date":509,"type":41},"2025-04-25",{"date":511,"type":21},"2027-04",{"name":513,"class":48},"Jaeb Center for Health Research",10]