[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pregnancy-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pregnancy-complications":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,45,92,119,148,176,201,219,241,274,309,335,373,394,425,453,477,512,543,577,607,635,658,682,708],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643973","advancing-stillbirth-prevention-through-innovative-risk-evaluation-aspire-clinical-study-100643973",false,"NCT07669935","Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study","A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications","ASPIRE","Inclusion Criteria:\n\n* Age ≥18 years\n* Nulliparous (no previous births ≥20wk GA)\n* Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0\u002F7-17 6\u002F7 weeks of gestation\n* Ability to consent and comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Multiple gestation\n* Inability to provide blood\n* Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual\n* Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)\n* Current or recent (within two months) participation in an interventional clinical study.",true,"FEMALE","18 Years","99 Years",{"count":23,"type":24},5500,"ESTIMATED","OBSERVATIONAL","ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \\[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\\] and risk of adverse outcomes.",[28,29,30,31,32],"GDM","Preterm Preeclampsia","Preeclampsia","Fetal Growth Restriction (FGR)","Pregnancy Complications","NOT_YET_RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":24},"2026-07-30",{"date":41,"type":24},"2028-12-01",{"name":43,"class":44},"Medicines360","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":80,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442","NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","PTBCARE+","Inclusion Criteria:\n\n1. Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 2763g 6 lbs 1.5 oz \\> 2379g 5 lbs 3.9 oz 35 weeks \\> 3084g 6 lbs 12.8 oz \\> 2661g 5 lbs 13.9 oz\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC).\n\nExclusion Criteria:\n\n1. Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and\u002For confound the study results.\n\n   o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. If a major congenital anomaly is diagnosed \\*after\\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.\n8. Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.\n\n   * Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.\n   * The term \"suspected aneuploidy\" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.",{"count":54,"type":24},1228,"INTERVENTIONAL",[57],"NA","The goal of this clinical trial is to learn if a personalized prenatal support program \\[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \\& Beyond, (PTBCARE+)\\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\\[s\\] it aims to answer are:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.\n* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.\n\nPeople who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[60,61,62,30,63,64,65,66,67,68,69,70,32,71,72,73,74,75,76,77,78,79],"Preterm Birth Complication","Preterm Birth","Preterm Birth Recurrence","Preeclampsia (PE)","Hypertensive Disorders of Pregnancy","Support Program","Stress","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy","Pregnancy Induced Hypertension","Neonates and Preterm Infants","Cervical Insufficiency","Social Determinants of Health (SDOH)","Cervical Shortening","Disparities in Pregnancy Complications","Disparities","Prenatal Care","Care Coordination",[51,81,82,83],"pregnancy-related disparities","patient support program","enhanced prenatal care",{"date":36,"type":37},{"date":86,"type":24},"2026-08-01",{"date":88,"type":24},"2029-01",{"name":90,"class":44},"University of North Carolina, Chapel Hill",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":18,"sex":19,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":55,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100578685","delivering-hope-helping-women-optimize-prenatal-equity-100578685","NCT06814509","Delivering HOPE (Helping Women Optimize Prenatal Equity)","Inclusion Criteria:\n\n* Aged 16-44 years\n* ≤18 weeks pregnant\n* Speak English, Spanish, or Marshallese\n* Valid email address","16 Years","44 Years",{"count":101,"type":24},1440,[57],"The overarching research question is: \"Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?\" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000\u002F$2000\u002F$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.",[105,106,107,108,32],"Gestational Weight Gain","Diet, Healthy","Gestational Hypertension","Gestational Diabetes","RECRUITING",{"date":111,"type":37},"2026-06-26",{"date":113,"type":37},"2025-06-24",{"date":115,"type":24},"2029-12-31",{"name":117,"class":44},"University of Arkansas",8,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":55,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":91},"100641438","physical-activity-in-bed-rest-hospitalized-high-risk-pregnant-women-100641438","NCT07657000","Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.","Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women","BedRest-1","Inclusion Criteria:\n\n* Maternal age of 18 or more\n* Delivery not expected within 1 week after recruitment.\n* Language ability to understand the study.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Fetal death\n* Severe mental health disorders and substance abuse disorders.",{"count":128,"type":24},140,[57],"This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even while in bed and seeks to address physical and emotional health challenges during hospitalization. The study will compare outcomes between participants who follow the exercise program and those receiving standard care. Primary outcomes include physical and emotional health parameters, quality of life, and sleep quality. Secondary outcomes focus on feasibility, adherence, and participant satisfaction. This research addresses the gap in physical activity guidelines for pregnant individuals on bed rest and explores the potential benefits of exercise to improve maternal well-being and postpartum recovery.",[132,70,32],"Bed Rest",[134,70,135,136,137,138],"Bed rest","Pregnancy complications","Hospitalization","Exercise","Exercise adaptations","2026-06-17",{"date":141,"type":37},"2026-06-18",{"date":143,"type":24},"2026-09",{"date":145,"type":24},"2029-09",{"name":147,"class":44},"Hospital Clinic of Barcelona",{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":28,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":55,"phases":157,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":91},"100635561","effects-of-leg-ergometer-versus-arm-ergometer-on-blood-glucose-exercise-tolerance-weight-and-psychological-stress-among-gestational-diabetic-patients-100635561","NCT07554287","Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients","Inclusion Criteria:\n\n1. Female participants aged 18-35 years.\n2. Gestational age 14-28 weeks (second trimester).\n3. Singleton pregnancy (confirmed by obstetric record) only to avoid complications of multiple gestation.\n4. Include both primigravida and multigravida (i.e., first or subsequent pregnancy).\n5. Women with first time GDM in pregnancy.\n6. Women with clinical diagnosis of gestational diabetes according to hospital\u002FWHO criteria or hospital diagnostic test.\n7. Blood glucose levels:\n\n   Random capillary glucose \\\u003C 200 mg\u002FdL at screening (to exclude overt diabetes)\n8. Blood pressure:\n\n   * Systolic BP \\\u003C 140 mmHg and Diastolic BP \\\u003C 90 mmHg (no confirmed gestational hypertension).\n   * If BP ≥140\u002F90 mmHg, confirm with repeat measurement 4 hours apart; exclude if persistent.\n9. Willingness to participate and provide written informed consent.\n10. Medically cleared by obstetrician to participate in moderate aerobic exercise.\n\nExclusion Criteria:\n\n1. Previous Cesarean section or medically indicated bed rest.\n2. Known pre-existing diabetes mellitus (Type 1 or Type 2 prior to pregnancy).\n3. Known major obstetric complications (e.g., placenta previa, severe pre- eclampsia).\n4. Patients having multiple\u002Ftwin\u002Ftriplet pregnancies.\n5. Known major fetal anomaly.\n6. Anemic women with Hb \\\u003C 9 g\u002FdL (excluded to prevent exercise intolerance).\n7. Uncontrolled cardiovascular disease, musculoskeletal, or medical contraindications to exercise.\n8. Psychiatric conditions severe enough to hinder informed consent.\n9. Any other medical condition that, in the opinion of the obstetrician, makes participation unsafe.","35 Years",{"count":156,"type":24},108,[57],"The current study is a single-blind, parallel-group randomized controlled trial involving 108 participants with diabetes during pregnancy. The trial will compare leg ergometer with arm ergometer. Interventions will be delivered three times per week for eight weeks. The primary outcomes are glucose, exercise tolerance, weight, and psychological stress. Assessments will be conducted at baseline and after eight weeks. The trial will be carried out at Jinnah hospital, Services hospital, Sir Ganga Ram Hospital, Lahore. The hypothesis is that the leg ergometer including aerobic exercise will result in greater reduction in glucose and exercise tolerance, weight and stress management than arm ergometer.",[160,32,161,162,163,164],"Diabetes During Pregnancy","Pregnancy in Diabetes","Gestational Diabetes Mellitus (GDM)","Diabetes Complication","Gestational",[166,167,28,164],"gestational diabetes","diabetes in pregnancy","2026-06-16",{"date":141,"type":37},{"date":171,"type":37},"2026-05-26",{"date":173,"type":24},"2026-10-15",{"name":175,"class":44},"Lahore University of Biological and Applied Sciences",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":91},"100546657","navigating-pregnancy-and-parenthood-with-lyme-disease-100546657","NCT06397794","Navigating Pregnancy and Parenthood With Lyme Disease","Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease","Inclusion Criteria:\n\n* Over 18 years of age and reside in the United States or Canada\n* Diagnosed with acute Lyme disease, PTLDS, and\u002For Chronic Lyme by a health care provider while they were pregnant OR PTLDS\u002FCL prior to becoming pregnant with ongoing symptoms during pregnancy\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Live outside of the United States or Canada\n* Never been diagnosed with Lyme disease by a medical provider\n* Never been pregnant\n* Never given birth to a liveborn infant\n* Previously participated in a qualitative study about their experience with Lyme disease\n* Do not want to agree to having their interviews audio recorded",{"count":184,"type":24},30,"This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and\u002For chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.",[187,188,189,190,191,32,192],"Lyme Disease","Post Treatment Lyme Disease","Chronic Lyme Disease","Tick-Borne Infections","Tick-Borne Diseases","Parenting","2026-06-15",{"date":139,"type":37},{"date":196,"type":37},"2024-03-20",{"date":198,"type":24},"2026-12",{"name":200,"class":44},"Children's National Research Institute",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":207,"minAge":20,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":218,"locationsCount":91},"100518163","pregnancy-and-early-neurodevelopmental-outcomes-following-in-utero-lyme-disease-exposure-100518163","NCT06026969","Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure","Inclusion Criteria:\n\n* English speaker\n* Currently reside in the United States or Canada\n* Meet CDC criteria for: (1) clinical and\u002For laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR (2) clinical diagnosis of PTLDS\u002FChronic Lyme within 3 years of current pregnancy\n* Able to be contacted for follow-up\n\nExclusion Criteria:\n\n* Intellectually unable to comprehend study procedures\n* Health issues or metallic implant that precludes undergoing MRI\n* Incapable of completing study requirements (note: inability to travel to Children's National for in-person follow-up \\[for example, due to bedrest, travel restrictions, or financial inability to travel\\] is NOT an exclusion criterion; any interested and eligible participants requiring \"remote only\" participation will be permitted to join the study and complete all requirements besides in-person follow-up)","ALL",{"count":209,"type":24},40,"The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.",[187,212,189,190,32,213],"Post-Treatment Lyme Disease","Child Development",{"date":168,"type":37},{"date":216,"type":37},"2023-07-01",{"date":198,"type":24},{"name":200,"class":44},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100544329","feasibility-and-acceptability-of-hcv-treatment-in-pregnancy-100544329","NCT06367465","Feasibility and Acceptability of HCV Treatment in Pregnancy","Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy","Inclusion Criteria:\n\n* Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c virus infection and a history of past or current drug use.\n\nExclusion Criteria:\n\n\\-",{"count":227,"type":24},50,"Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use\n\nParticipant Duration: Approximately 1 year.\n\nAims:\n\nAim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.\n\nAim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.",[230,32],"Hepatitis C","2026-06-05",{"date":233,"type":37},"2026-06-09",{"date":235,"type":37},"2024-02-01",{"date":237,"type":24},"2026-12-28",{"name":239,"class":44},"Washington University School of Medicine",2,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":55,"phases":251,"briefSummary":253,"conditions":254,"keywords":264,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":91},"100537733","phase-4-treatment-with-aspirin-after-preeclampsia-tap-trial-100537733","NCT06281665","Treatment With Aspirin After Preeclampsia: TAP Trial","TAP","Inclusion Criteria:\n\n* Postpartum individuals ≥18 years old\n* Preeclampsia diagnosis\n\nExclusion Criteria:\n\n* Fetal anomaly\n* Multiple gestation\n* Pre-pregnancy hypertension\n* Allergy or contraindication to low-dose aspirin\n* Pre-pregnancy diabetes","55 Years",{"count":250,"type":24},60,[252],"PHASE4","The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and\u002For microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.",[255,256,257,258,107,259,260,32,261,262,263],"Hypertensive Disorder of Pregnancy","Pre-Eclampsia","Hypertension","Eclampsia","Cardiovascular Diseases","Toxemia","Vascular Diseases","Hypertension, Pregnancy Induced","Hypertension;Pre-Eclamptic",[257],"2026-06-03",{"date":267,"type":37},"2026-06-04",{"date":269,"type":37},"2024-05-29",{"date":271,"type":24},"2027-09-01",{"name":273,"class":44},"Malamo Countouris",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":284,"conditions":285,"keywords":291,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100637506","feasibility-trial-of-the-womb-watch-smartphone-app-to-assess-fetal-movements-100637506","NCT07626112","Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements","A Pilot Study of the Womb Watch App: Fetal Assessment Using the Microphone of the Smartphone","WWA","Inclusion Criteria:\n\n* Ability to understand and voluntarily provide written signed informed consent to participate in the study.\n* English speaking (the alpha version of the Womb Watch app is only available in English)\n* Singleton intrauterine pregnancy\n* Estimated gestational age at enrollment 28 weeks to 32 weeks\n* Low-risk pregnancy with normal fetal growth and anatomy and no maternal co-morbidities of note.\n* High-risk pregnancy including fetal anomalies and maternal co-morbidities including but not limited to cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine\u002Fmetabolic, immunologic, dermatologic, neurologic, or oncologic.\n* No prior diagnosis of an anxiety mood disorder or a psychiatric illness\n* Access to internet\n* A functioning email address\n* Owns personal smartphone; iPhone or Android of any generation\n\nExclusion Criteria:\n\n* Currently pregnant with multiples (twins or more)\n* Baseline GAD-7 score of 10 or more","45 Years",{"count":250,"type":24},"The surveillance of pregnancies at risk for fetal loss secondary to high-risk maternal or fetal conditions remains a mainstay of perinatal care. Current testing to prevent fetal loss includes the regular use of ultrasound (biophysical profile) or fetal heart rate monitoring (non-stress test) in an outpatient clinic setting once or twice weekly. A patient may also be asked to subjectively assess daily fetal movements during the time between routine antepartum testing appointments. However, there are no good systems for pregnant women to objectively measure fetal movements. Smartphones have allowed for the development of applications that utilize various embedded devices including the camera and microphone.\n\nIn our recent pilot STUDY00001552 of 205 pregnant patients, placement of the iPhone10 microphone directly on the maternal abdominal wall was utilized to detect fetal movements. AI assessment of the audio recordings proved superior to maternal perception of fetal movements that were recorded during simultaneous ultrasound (gross fetal movements: 64% audio vs 18% maternal; breathing: 93% vs 3%, hiccups: 73% vs 3%).\n\nThis trial is a prospective, observational, feasibility study of 60 patients that includes both low-risk and high-risk pregnant women to examine the usability of the Womb Watch smartphone application.\n\nThe study will involve introduction of the Womb Watch app to a population of pregnant patients. Features of the app will be modified based on participant feedback. Anxiety levels of the patient will be tracked serially using a survey tool. The various types and versions of smartphones will be assessed to see if they affect the AI model. Finally, patients will be asked to determine the strength of fetal movements to see if this parameter can be assessed by the AI model. Amniotic fluid data will assessed through clinical ultrasounds to see if this also has any effect on the AI model's ability to detect fetal movements.",[286,70,32,287,288,289,290],"Assessment of Fetal Movement","Pregnancy Complications Affecting Fetus (Diagnosis)","Stillbirth","Stillbirth and Neonatal Mortality","Fetal Movement",[292,293,294,295,296,297,298,299],"fetal movement","stillbirth","pregnancy","decreased fetal movement","IUFD","fetal demise","fetal kick counting","antenatal testing","2026-05-30",{"date":267,"type":37},{"date":303,"type":24},"2026-07-01",{"date":305,"type":24},"2027-09-30",{"name":307,"class":44},"Kenneth Moise MD",3,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":55,"phases":318,"briefSummary":319,"conditions":320,"keywords":323,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":91},"100640668","clinician-notification-to-increase-aspirin-prophylaxis-for-preeclampsia-prevention-100640668","NCT07614893","Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention","A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia","Inclusion Criteria:\n\n* Pregnant individuals receiving outpatient obstetric care at participating medical centers.\n* Age 18 years or older.\n* Currently pregnant and within 12 to 28 weeks' gestation\n* Identified as having elevated predicted risk for preeclampsia as defined by USPSTSF and ACOG criteria\n* Receiving care from a clinician, care team, or clinic participating in the randomized implementation trial.\n\nExclusion Criteria:\n\n* Known contraindication to aspirin prophylaxis documented in the electronic health record.\n* Pregnancy beyond the prespecified gestational age window for aspirin prophylaxis implementation at the time of eligibility assessment.\n* Not receiving ongoing obstetric care at a participating site.",{"count":317,"type":24},1000,[57],"Preeclampsia is a leading cause of maternal morbidity and mortality. Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice. This pragmatic cluster-randomized implementation trial will test whether clinician notification of elevated preeclampsia risk increases aspirin prophylaxis utilization among eligible pregnant individuals receiving outpatient obstetric care.\n\nClusters will be randomized to clinician notification versus usual care. In the intervention arm, obstetric clinicians will receive notification that a patient is at elevated risk for preeclampsia and a recommendation to consider initiation of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. The intervention does not assign participants to aspirin and does not require any study-mandated medication. All decisions regarding aspirin prophylaxis will remain at the discretion of the treating obstetric clinician and patient.",[30,321,32,322],"Hypertensive Disorders of Pregnancy (HDP)","Aspirin Prophylaxis",[324,325],"preeclampsia","aspirin prophylaxis","2026-05-22",{"date":328,"type":37},"2026-05-29",{"date":330,"type":24},"2027-05",{"date":332,"type":24},"2030-05",{"name":334,"class":44},"Massachusetts General Hospital",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":282,"enrollmentInfo":342,"targetDuration":4,"studyType":55,"phases":343,"briefSummary":344,"conditions":345,"keywords":350,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":91},"100582284","placental-imaging-techniques-100582284","NCT06861309","Placental Imaging Techniques","Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction","Inclusion Criteria:\n\n* Normal-Fetal-Weight Pregnancies Arm: Patient at least 18 to 45 years of age at screening\n* Normal-Fetal-Weight Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders or growth abnormalities\n* Normal-Fetal-Weight Pregnancies Arm: Low-risk aneuploidy screening, if performed\n* Normal-Fetal-Weight Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)\n* Normal-Fetal-Weight Pregnancies Arm: Anatomical survey has been performed\n* Normal-Fetal-Weight Pregnancies Arm: Pregnancy without current fetal growth restriction (FGR) diagnosis\n* Normal-Fetal-Weight Pregnancies Arm: Subject willing and able to provide informed consent Note: Verify that the most recent version of the ICF was used to consent the subject\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Patient at least 18 to 45 years of age at screening\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Low-risk aneuploidy screening, if performed\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Anatomical survey has been performed\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Pregnancy diagnosed with fetal growth restriction (FGR) by estimated fetal weight \\\u003C10th centile or abdominal circumference measurements \\\u003C10th centile\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Subject willing and able to provide informed consent Note: Verify that the most recent version of the ICF was used to consent the subject\n\nExclusion Criteria:\n\n* Normal-Fetal-Weight Pregnancies Arm: Multiple gestations\n* Normal-Fetal-Weight Pregnancies Arm: Known fetal anomaly affecting biometric measurements\n* Normal-Fetal-Weight Pregnancies Arm: Suspected fetal genetic disorder(s)\n* Normal-Fetal-Weight Pregnancies Arm: Suspected fetal infection(s)\n* Normal-Fetal-Weight Pregnancies Arm: Non-English or Spanish-speaking\n* Normal-Fetal-Weight Pregnancies Arm: Unstable housing or transportation\n* Normal-Fetal-Weight Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Multiple gestations\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Known fetal anomaly affecting biometric measurements\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal genetic disorder(s)\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal infection(s)\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-English or Spanish-speaking\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Unstable housing or transportation\n* Fetal-Growth-Restricted (FGR) Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.",{"count":250,"type":24},[57],"The goal of this proof-of-concept, case-control, clinical trial is to evaluate the efficacy of using two newer ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), to evaluate the health of the placenta, visualize blood flow through the placental vasculature by color Doppler imaging in singleton pregnancies with and without fetal growth restriction (FGR).\n\n* Our primary objective is to investigate the ability of using these ultrasound technologies to distinguish healthy pregnancies from those affected by FGR, a condition characterized by a fetal weight below the 10th percentile for the gestational age or abdominal circumference of the pregnancy.\n* Secondary aims include longitudinal evaluation of differences in QUS and uPDI imaging over gestation and changes in these measures with evolution of utero-placental insufficiency including with the development of abnormal umbilical-artery Doppler testing, diagnosis of severe FGR, identification of stillbirth, and detection of preeclampsia or preterm birth.\n\nInvestigators will compare QUS\u002FuPDI imaging and values in pregnancies determined to be healthy by approved, standard-of-care growth ultrasounds to those diagnosed with FGR.\n\nParticipants will receive research ultrasounds with the experimental Verasonics Vantage 256 system (Verasonics, Inc, Kirkland, WA) utilizing uPDI\u002FQUS every three weeks following their routine growth ultrasound evaluation until delivery. Demographic, obstetric, and delivery-related information, as well as portions of subjects' past medical history will be utilized by researchers to further contextualize imaging and variables gathered during the research ultrasounds.",[31,346,30,347,70,32,348,349],"Placental Insufficiency","Still Births","Pregnancy Outcomes","Ultrasound",[351,352,353,354,355,349,70,32,356,357,358,359,360,361,288,30,362,363,364,365],"Fetal Growth Restriction","FGR","Placental Imaging","Utero-Placental Insufficiency","Growth Restriction","Maternal Fetal Medicine","Ultrafast Power Doppler Imaging","Quantitative Ultrasound","uPDI","QUS","MFM","Verasonics","Verasonics Vantage 256","Carilion Clinic","Virginia Tech","2026-05-20",{"date":326,"type":37},{"date":369,"type":37},"2025-04-23",{"date":371,"type":24},"2026-11",{"name":364,"class":44},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":55,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":91},"100378270","sleep-behaviors-in-pregnancy-100378270","NCT04205370","Sleep Behaviors in Pregnancy","Inclusion Criteria:\n\n* At least 28 weeks pregnant\n* Receiving pre-natal care at Michigan Medicine\n* Have either and Android or iPhone smartphone\n\nExclusion Criteria:\n\n* Less then 28 weeks pregnant\n* Receiving pre-natal care external to Michigan Medicine\n* Does not poses a smartphone",{"count":380,"type":24},500,[57],"The researchers would like to know how long pregnant women spend in different positions during the night - and how often women change positions - across pregnancy. The researchers also want to see if the sleep monitor is able to improve sleep behaviors",[384,32],"Sleep","2026-05-07",{"date":387,"type":37},"2026-05-11",{"date":389,"type":37},"2020-01-22",{"date":391,"type":24},"2027-12",{"name":393,"class":44},"University of Michigan",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":207,"minAge":20,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":55,"phases":403,"briefSummary":404,"conditions":405,"keywords":410,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100459604","the-periviable-goals-decision-support-tool-100459604","NCT05264779","The Periviable GOALS Decision Support Tool","Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool","Inclusion Criteria for Pregnant Persons:\n\n* Adults (18 years or older)\n* Pregnant between 22 0\u002F7 to 25 6\u002F7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution).\n* Presenting to Labor \\& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction).\n* Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team.\n\nInclusion Criteria for Important Others:\n\n* Adults (18 years or older)\n* 1 per pregnant person\n* Is identified by the pregnant person as someone who will be involved in making decisions for the baby\n* Must be present at the time of randomization to participate\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Incarcerated\n* Medically unstable (i.e. in active labor and dilated 6cm or more)\n* Emotionally unstable\n* Have not been counseled by their healthcare team regarding neonatal treatment options\n* Are not admitted to Labor \\& Delivery for reasons indicative of a threatened early delivery\n* If they are experiencing a known fatal fetal anomaly\n* Are not present at the time of randomization (only for important others)",{"count":402,"type":24},300,[57],"The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0\u002F7 - 25 6\u002F7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.",[406,407,32,408,409],"Pregnancy Preterm","Premature Birth","Obstetric Labor, Premature","Obstetric Labor Complications",[411,412,413,414,415],"Decision making","Periviable delivery","Preterm birth","Risk Communication","Neonatal Resuscitation","2026-05-06",{"date":387,"type":37},{"date":419,"type":37},"2022-06-06",{"date":421,"type":24},"2027-02",{"name":423,"class":44},"Indiana University",12,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":55,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":4},"100640472","bed-rest-with-a-short-cervix-on-preterm-birth-100640472","NCT07577388","Bed Rest With a Short Cervix on Preterm Birth","BEWISE - Bed Rest With a Short Cervix on Preterm Birth","BEWISE","Pregnant women with gestational age 20+0 to 33+6\n\n* Cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies\n* Above 18 years of age\n* Reads and understands Danish or English",{"count":434,"type":24},6000,[57],"Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.\n\nThe use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects.\n\nThe overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR).\n\nThe primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix.\n\nSecondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density.\n\nThrough the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria.\n\nThe primary outcome is gestational age in days (continuous).",[61,73,132,32,438,439,440,441,442,407,408,443,444],"Immobilization","Depression, Postpartum","Pregnancy Outcome","Infant, Premature","Uterine Cervical Incompetence","Physical Activity","Bone Density","2026-05-03",{"date":387,"type":37},{"date":448,"type":24},"2026-05-01",{"date":450,"type":24},"2029-05-01",{"name":452,"class":44},"Julie Glavind",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":91},"100576025","autophagyapoptosis-balance-in-placental-vascular-pathologies-100576025","NCT06779916","Autophagy\u002FApoptosis Balance in Placental Vascular Pathologies","Study of the Autophagy\u002FApoptosis Balance in Placental Vascular Pathologies","GROSSAUTOP-2","Inclusion Criteria:\n\n* Pregnant women developing a placental vascular complication (preeclampsia and\u002For intrauterine growth retardation), hospitalized and delivering at Nimes University Hospital.\n* Pregnant woman with free and informed consent.\n* Pregnant woman affiliated with and\u002For benefiting from a health insurance scheme.\n\nExclusion criteria:\n\n* Multiple pregnancy.\n* Presence of hypertension and\u002For proteinuria prior to pregnancy.\n* Participant in an interventional drug study.\n* Persons in a period of exclusion determined by another study.\n* Persons under court protection, guardianship or curatorship.\n* Persons unable to give consent.\n* Persons for whom it is impossible to give informed information.",{"count":227,"type":24},"Pregnancy increases the risk of thrombosis. Placenta-mediated diseases are a risk factor for cardiovascular pathologies and can lead to maternal-fetal morbidity and mortality. It is essential to understand the cellular and molecular mechanisms of dysfunctions at the vascular-placental interface so that systemic vascular risk can be characterized and, ultimately, screened for, on the basis of new markers (targeted preventive management).\n\nDeregulated autophagy could be the starting point for cell death by apoptosis or necrosis leading to complications.\n\nThe pathophysiological mechanisms involved in trophoblast apoptosis are incompletely described. This project follows on from the GrossAuTop-1 study, which investigated the intra- and inter-individual variability of autophagy and apoptosis activities in women during pregnancy. The aim of this project is to study autophagy and apoptosis activities specifically in women developing a placental vascular complication during pregnancy.",[32,256,464],"Growth Retardation, Intrauterine",[466,467,468,469,294],"trophoblasts","autophagy","apoptosis","placenta","2026-04-30",{"date":416,"type":37},{"date":473,"type":37},"2025-05-02",{"date":450,"type":24},{"name":476,"class":44},"Centre Hospitalier Universitaire de Nīmes",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":282,"enrollmentInfo":485,"targetDuration":486,"studyType":25,"phases":4,"briefSummary":487,"conditions":488,"keywords":495,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":91},"100636441","cardiometabolic-disease-and-substrate-metabolism-100636441","NCT07565727","Cardiometabolic Disease and Substrate Metabolism","Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study","CAP","Inclusion Criteria:\n\n* Age 18-45\n* Any pre-pregnancy BMI\n* At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines\n* Willingness to adhere to aspirin therapy\n* Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.\n* Gestational age at enrollment \\\u003C18 weeks\n* Ability to speak, read, and communicate via English\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Type 1 Diabetes Mellitus\n* Current gestational diabetes mellitus\n* Current\u002Factive platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura\u002FITP, thrombotic thrombocytopenic purpura\u002FTTP, von Willebrand disease, etc.)\n* Thrombophilia\n* Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)\n* Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)\n* Current or recent use of steroids\n* Current use of prophylactic or therapeutic anticoagulation\n* Medical contraindication to aspirin therapy\n* Molar pregnancy\n* Renal disease\n* Inability or unwillingness to give informed consent\n* Current psychiatric illness\u002Fsocial situation that would limit compliance with study requirements, as determined by the principal investigators",{"count":227,"type":24},"9 Months","This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.",[30,162,63,489,108,490,491,492,493,70,32,494],"Preeclampsia (PE) Risk","Gestational Diabetes Mellitus in Pregnancy","Cardiometabolic Diseases","Insulin Resistance","Placental Dysfunction","Gestational Complications",[496,497,30,108,498,499,500,501,502],"Cardiometabolic disease","Substrate metabolism","Insulin resistance","HOMA-IR","Lipid oxidation","Placental dysfunction","Chorangiosis","2026-04-27",{"date":505,"type":37},"2026-05-04",{"date":507,"type":37},"2025-12-10",{"date":509,"type":24},"2027-08",{"name":511,"class":44},"University of Tennessee Graduate School of Medicine",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":522,"conditions":523,"keywords":529,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":91},"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":227,"type":24},"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.",[524,525,526,527,32,528],"Anxiety Disorders","Stress Disorders, Post-Traumatic","Pregnancy, High Risk","Depressive Disorder, Major","ADHD - Attention Deficit Disorder With Hyperactivity",[530,531,518,532,533,534],"Collaborative Mental Health Care Program","Inpatient high-risk pregnancy support","High-risk pregnancy mental health","Perinatal psychotherapy","Trauma-informed therapy","2026-04-18",{"date":537,"type":37},"2026-04-22",{"date":539,"type":24},"2026-06-01",{"date":541,"type":24},"2027-06-01",{"name":423,"class":44},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":55,"phases":553,"briefSummary":554,"conditions":555,"keywords":562,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":91},"100594452","u-cavit-versus-standard-of-care-for-prevention-of-atonic-postpartum-hemorrhage-after-cesarean-section-in-high-risk-women-100594452","NCT07019623","U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.","Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.","UCaVIT Pilot","Inclusion Criteria:\n\n* Signed informed consent\n* Maternal age ≥18 years\n* Gestational age ≥30+0 weeks of pregnancy at day of delivery\n* Vital pregnancy\n* Delivery mode: planned cesarean delivery\n* High-risk patient for PPH specified by the presence of at least one of the following characteristics: Previous PPH, obesity (BMI ≥30 kg\u002Fm2), high parity (patient who has had ≥4 previous births (live or stillborn) at ≥20 weeks of gestation), very advanced maternal age ≥45 years, multiple gestation, polyhydramnios (defined as amniotic fluid index \\> 25 cm or deepest amniotic fluid pocket \\> 8 cm) at admission to delivery, suspected fetal macrosomia (estimated fetal weight ≥ 4500g)\n\nExclusion Criteria:\n\n* Insufficient language skills in German or English to understand and sign informed consent\n* Participation in another interventional study\n* Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)\n* Subjects who change their delivery plan from vaginal to cesarean section in the course of hospitalization\n* Women with regular and painful contractions and women who do not have time for sufficient consideration\n* Clinical situations in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated:\n\n  * Uterine or vaginal anomalies (genital tract congenital anomalies)\n  * Cesarean section due to placenta previa or suspected placenta accreta spectrum\n  * Suspected uterine rupture\n  * Injuries of the cervix or vagina\n  * Submucous or intramural uterine fibroids which are buldging into the uterine cavity\n  * Deep endometriosis \\[16, 17\\]\n* Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin\n* Previous MMC-repair (myelomeningocele-repair)\n* Clinical diagnosis of chorioamnionitis, sepsis\n* Known allergy to silicone\n* Known and proven diagnosis of bleeding disorder or thrombophilia\n* Known thrombocytopenia during second half of pregnancy with thrombocytes \\\u003C 100 G\u002FL\n* Known anemia during second half of pregnancy with Hb\\\u003C80",{"count":552,"type":24},70,[57],"This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery.\n\nThe U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.",[556,557,558,559,32,560,561],"Postpartum Hemorrhage (Primary)","Hemorrhage","Postpartum Complication","Delivery ,Complications,Maternal","Cesarean Delivery","Balloon",[563,564,565,70,566,567,568,569],"Postpartum Hemorrhage","Delivery complications","high risk patients","Balloon Catheter","Tamponade","prophylactic","Vacuum-induced tamponade","2026-04-17",{"date":537,"type":37},{"date":573,"type":37},"2025-05-28",{"date":371,"type":24},{"name":576,"class":44},"Christian Haslinger",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":18,"sex":207,"minAge":20,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":587,"conditions":588,"keywords":594,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":308},"100633895","microbiome-and-metabolome-profiles-in-couples-undergoing-ivf-and-reproductive-outcomes-100633895","NCT07532629","Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes","Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study","Mi IVF","Inclusion Criteria:\n\n* Women aged 18 to 40 years at enrolment.\n* Men aged between 18 to 56 years at enrolment.\n* Couples planning to undergo IVF treatment at a participating centre.\n* Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.\n\nExclusion Criteria:\n\n* Pregnancy at the time of enrolment (confirmed or suspected).\n* Recent systemic antibiotic use within the past 4 weeks\n* Active vaginal or genital tract infection at the time of sampling","40 Years",{"count":317,"type":24},"This prospective observational cohort study investigates the role of the microbiome and metabolome in couples undergoing in vitro fertilization. Biological samples will be collected from both female and male partners, including semen, vaginal, and blood samples, to characterize microbial composition and metabolic profiles. The study aims to examine how these biological profiles are associated with reproductive outcomes such as fertilization, pregnancy, miscarriage, and live birth. Participants will be followed longitudinally, and reproductive and obstetric outcomes will be obtained through linkage with national health registers.",[589,590,32,591,592,593],"Infertility","Assisted Reproductive Technology","Pregnancy Loss, Early","Metabolome","Microbiome",[595,593,592,596,597],"IVF","Male fertility","Pregnancy outcome","2026-04-13",{"date":600,"type":37},"2026-04-16",{"date":602,"type":37},"2022-06-10",{"date":604,"type":24},"2029-03-01",{"name":606,"class":44},"Karolinska Institutet",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":615,"enrollmentInfo":616,"targetDuration":486,"studyType":25,"phases":4,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":633,"locationsCount":91},"100632724","glycemic-markers-for-predicting-gestational-diabetes-in-pregnant-women-with-previous-bariatric-surgery-100632724","NCT07517406","Glycemic Markers for Predicting Gestational Diabetes in Pregnant Women With Previous Bariatric Surgery","Predictive Value of Glycemic Markers for Gestational Diabetes Mellitus and Pregnancy Complications in Pregnant Women With Prior Bariatric Surgery Who Cannot Tolerate Oral Glucose Tolerance Testing","BARI-GDM","Inclusion Criteria\n\n* Pregnant women aged 18-50 years\n* Singleton pregnancy\n* History of bariatric surgery prior to pregnancy\n* Followed at Prof. Dr. Cemil Taşcıoğlu City Hospital, Department of Obstetrics and Gynecology\n* Availability of glycemic parameters during early pregnancy (≤14 weeks) and\u002For between 24 and 28 weeks of gestation (fasting plasma glucose, HbA1c, urine glucose, and\u002For OGTT results if tolerated)\n* Availability of sonographic and clinical follow-up data between 28 weeks of gestation and delivery (up to 40 weeks) Exclusion Criteria\n* Age \\\u003C18 years or \\>50 years\n* Multiple pregnancy\n* Presence of known chronic systemic disease (e.g., pregestational diabetes or endocrine disorders)\n* Incomplete or missing clinical data","50 Years",{"count":617,"type":24},84,"Gestational diabetes mellitus (GDM) is associated with significant maternal and fetal complications. The standard diagnostic test for GDM is the 75-gram oral glucose tolerance test (OGTT). However, pregnant women who have undergone bariatric surgery may not tolerate OGTT due to dumping syndrome and gastrointestinal side effects. This creates diagnostic challenges in this specific population.\n\nThe aim of this prospective observational study is to evaluate whether routinely measured glycemic markers, including fasting blood glucose, postprandial blood glucose, HbA1c, and urinary glucose levels, can predict the development of gestational diabetes mellitus and related pregnancy complications in women with prior bariatric surgery.\n\nPregnant women aged 18-50 years with a history of bariatric surgery will be enrolled and followed throughout pregnancy. The predictive value of glycemic markers for GDM, macrosomia, and polyhydramnios will be analyzed using multivariable logistic regression models.\n\nThis study aims to provide alternative diagnostic approaches for GDM screening in pregnant women who are unable to tolerate OGTT and to contribute to improving maternal and perinatal outcomes in this growing patient population.",[162,32,620],"History of Bariatric Surgery",[622,623,624,625,626],"Gestational Diabetes Mellitus","Bariatric Surgery","Glucose Intolerance","Glycemic Markers","Oral Glucose Tolerance Test","2026-04-01",{"date":629,"type":37},"2026-04-08",{"date":631,"type":37},"2026-02-01",{"date":391,"type":24},{"name":634,"class":44},"Burak Deniz Aydoğdu",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":585,"enrollmentInfo":642,"targetDuration":4,"studyType":55,"phases":644,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":656,"locationsCount":308},"100297442","phase-2-impact-study-improve-pregnancy-in-aps-with-certolizumab-therapy-100297442","NCT03152058","IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy","Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)","Inclusion Criteria:\n\n* Pregnant as defined by positive test for elevated ß-HCG and having a live, appropriate sized embryo by ultrasound, but \\\u003C8 weeks gestation;\n* Antiphospholipid syndrome (APS);\n* Positive for LAC on two or more occasions greater than 12 weeks apart within the previous 18 months. If a candidate for the study is newly diagnosed (\\\u003C12 weeks) with APS, meets clinical criteria for APS and has one positive LAC confirmed by review of the medical record, she may be consented and screened. At baseline, LAC will be measured at the study core lab and she will be enrolled if it is found to be positive. The LAC measurement will be repeated 12 weeks after the initial determination and, if positive, she will remain in the study.\n* Age 18-40 (+364 days) years of age and able to give informed consent\n* Laboratory hematocrit \\>26% at time of screening.\n\nthe diagnosis of APS and LAC will be confirmed by one of the Co-PI's for each case by a review of the medical records.\n\nExclusion Criteria:\n\n* Hypertension (BP \\>140\u002F90) present at screening;\n* Multifetal gestation;\n* Type 1 or Type 2 diabetes antedating pregnancy;\n* SLE patients requiring prednisone \\>10 mg\u002Fday;\n* Platelet count \\\u003C100,000 per microliter;\n* Women currently taking prednisone greater than 10 mg daily for an autoimmune disorder, other than immune thrombocytopenia;\n\n  a. More than 60 mg once daily in a tapering regimen or 20 mg once daily in a maintenance regimen for immune thrombocytopenia\n* Women with urinary excretion with greater than 500 mg (0.5 g) per day (spot urine protein\u002Fcreatinine ration 0.5);\n* Serum creatinine \\>1.2 mg\u002FdL\n* History of tuberculosis or untreated positive PPD;\n* Women with a tuberculin skin test induration of 5 mm or greater; or positive quantiFERON-gold test\n* Women with HIV, Hepatitis B or Hepatitis C positive status;\n* Known contraindications or relative contraindications to certolizumab:\n\n  1. Active infection, e.g., chronic hepatitis B\n  2. History of recurrent infection, e.g., recurrent cellulitis, or opportunistic infection\n  3. History of prior active\u002Ftreated endemic mycoses in the last two years (including coccidioidomycosis, blastomycosis, or histoplasmosis)\n  4. History of heart failure\n  5. History of peripheral demyelinating disease or Guillian-Barre syndrome\n  6. History of hematologic malignancy\n  7. Prior adverse reaction to certolizumab or o ther anti-TNF-α agent",{"count":643,"type":24},55,[645],"PHASE2","This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.",[648,32,649,650],"High Risk Pregnancy","Antiphospholipid Syndrome in Pregnancy","Lupus Anticoagulant Disorder","2026-03-27",{"date":627,"type":37},{"date":654,"type":37},"2017-05-17",{"date":391,"type":24},{"name":657,"class":44},"David Ware Branch",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":664,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":681},"100588409","maternal-and-postnatal-outcomes-study-mos-a-global-observational-registry-assessing-the-safety-of-elfabrio-in-women-with-fabry-disease-and-their-infants-during-pregnancy-and-breastfeeding-100588409","NCT06941025","Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding","Maternal and Postnatal Outcomes Study (MOS) A Worldwide Decentralized Observational Registry to Evaluate the Safety in Women With Fabry Disease and Their Infants Exposed to Elfabrio® (Pegunigalsidase Alfa-iwxj\u002FPegunigalsidase Alfa) During Pregnancy and\u002For Lactation","MOS","Inclusion Criteria:\n\n* Female patients with Fabry disease who have been exposed to at least 1 dose of pegunigalsidase alfa at any time during pregnancy (defined as having received pegunigalsidase alfa within 30 days prior to the DOC and\u002For during pregnancy) and\u002For during lactation, and their infants.\n\n  o DOC, defined as 20\u002F7 gestational weeks, will be calculated from last menstrual period \\[LMP\\] or ultrasound\n* Patient or parent\u002Flegally authorized representative must be able to understand and provide consent through an Institutional Review Board \u002F Independent Ethics Committee (IRB\u002FIEC) approved Informed Consent Form.\n\nExclusion Criteria:\n\n* None",{"count":667,"type":24},10,"The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and\u002For during pregnancy and lactation.\n\nThe main objectives are to:\n\n* Assess pregnancy outcomes, including maternal and infant health.\n* Evaluate the occurrence of congenital malformations and other neonatal outcomes.\n\nThis is a global, decentralized, single-arm, prospective and retrospective registry planned to enroll participants over a 10-year period. Eligible patients may be enrolled by their physician or may self-enroll, where permitted by local regulations. Data will be collected through a secure web-based platform, allowing patients and physicians to enter information via electronic case report forms (eCRFs).\n\nPregnancy and clinical outcomes will be documented throughout pregnancy and up to 12 months post-birth. Data from self-enrolled patients will be confirmed by their primary care or attending physician. This registry is observational and does not impact clinical care or treatment decisions.",[670,70,32],"Fabry Disease","2026-03-17",{"date":673,"type":37},"2026-03-19",{"date":675,"type":37},"2025-05-23",{"date":677,"type":24},"2034-12",{"name":679,"class":680},"Chiesi Farmaceutici S.p.A.","INDUSTRY",5,{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":688,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":55,"phases":691,"briefSummary":692,"conditions":693,"keywords":695,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":703,"completionDateStruct":704,"leadSponsor":706,"locationsCount":4},"100609338","michigan-healthy-mom-mi-mom-pregnancy-improvement-web-application-trial-100609338","NCT07213284","Michigan Healthy Mom (MI-MOM) Pregnancy Improvement Web Application Trial","Site Randomized Trial to Evaluate Behavioral Intervention Via Web-Based Application (MI MOM- Michigan Healthy Moms Application) to Improve Pregnancy Outcomes","MI-MOM App","Inclusion Criteria:\n\n* Pregnant at 20 weeks gestation or less\n* 18 years of age or older\n* Access to smartphone with text messaging and internet access\n* Speaks English\n* Enrolled in Medicaid for health insurance\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Not pregnant or pregnant with more than 20 weeks gestation\n* No access to a smartphone with text messaging and internet access\n* Not English speaking\n* Not enrolled in Medicaid for health insurance",{"count":380,"type":24},[57],"The purpose of this research study is to see if using the MI MOM App improves pregnancy and postpartum health. There are two study groups, where one group is \"treatment as usual\" and the other is the \"MI MOM App\" group. Both groups will be asked to answer questions about their pregnancy health. Researchers will also retrieve vital records and Medicaid claims information related to pregnancy for both groups. Those in the \"MI MOM App\" group will receive mobile web app content and text messages with informational links and links to videos and micro-interventions. They will also identify up to three close friends or family members who will be invited to receive text messages. Those in the \"MI MOM App\" will also have the option to contact a community health worker as needed.",[70,694,348],"Pregnancy, Complications",[70,696,697,698,699],"App","Behavioral Intervention","Web-based Application","Postpartum","2026-03-10",{"date":702,"type":37},"2026-03-12",{"date":627,"type":24},{"date":705,"type":24},"2031-12-31",{"name":707,"class":44},"Michigan State University",{"id":709,"slug":710,"hasResults":12,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":714,"eligibilityCriteria":715,"healthyVolunteers":18,"sex":207,"minAge":4,"maxAge":4,"enrollmentInfo":716,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":717,"conditions":718,"keywords":730,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":739,"lastUpdatePostDateStruct":740,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":91},"100624813","hemophilia-a-research-program-100624813","NCT07414511","Hemophilia A Research Program","Hemophilia A Research Program (HARP): An Observational Intergenerational Cohort Study of Hemophilia A and Factor VIII Immunogenicity","HARP","Maternal Inclusion Criteria:\n\nPregnant individuals who meet the following criteria are eligible for enrollment as study participants:\n\n* Currently pregnant and prior to 37 weeks gestation\n* Known to have or at-risk of having a severe hemophilia A genotype\n* Pregnant with at least one fetus at-risk of inheriting severe hemophilia A\n* Ability to understand and willingness to provide informed consent\n* 18 years of age or older\n\nBefore the 38th week of pregnancy, enrolled participants must meet all the following criteria to continue to remain in the study:\n\n* The pregnant mother has a severe hemophilia A genotype.\n* A fetus is determined to have a \\>\u002F= 25% risk of inheriting severe hemophilia A, or prenatal testing indicates a fetus is affected by severe hemophilia A.\n* No other discontinuation criteria have been identified.\n\nPediatric Continuation \u002F Inclusion Criteria:\n\nEligibility of the child to continue is assessed by age 8 weeks. Mother-child pairs in which a child meets the following criteria will remain in the study:\n\n* Severe hemophilia A defined by a baseline FVIII:C \\\u003C 0.01 IU\u002FmL (or FVIII:C \\\u003C 1%) or a genotype predicted to cause severe hemophilia A\n* Born to a mother participating in the study\n\nThereafter, mothers and their children will continue in the study as long as no new discontinuation criteria occur.\n\nInclusion Criteria for Blood Relatives:\n\nBlood relatives of the child may be offered participation if one of the following criteria are met:\n\n* First-degree blood relatives (e.g., father, sibling) of the child\n* Second-degree blood relatives (e.g., aunt, uncle, grandparent, half-sibling) of the child\n* Any more distant male or female blood relative whose data or samples may be informative for the planned genetic studies of hemophilia and inhibitors\n\nExclusion\u002FDiscontinuation Criteria:\n\nMaternal: For the pregnant person, exclusion or discontinuation criteria are as follows:\n\n* Genetic testing is negative for a severe hemophilia A genotype\n* Prenatal clinical diagnostic testing that indicates there is no fetus affected with severe hemophilia A\n* Presence of another clinically significant bleeding disorder\n* Participation in another study for which any blood collection total would exceed safety limits defined in this study\n* Will deliver outside the United States or plans for regular pediatric care for the child to be delivered outside the United States\n* Is a prisoner\n* Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study\n* Inability for study team to obtain translated study documents in time for participation if participant is not fluent in English\n\nPediatric: For the child, discontinuation criteria are as follows:\n\n* Infant does not have severe hemophilia A defined by a baseline FVIII:C \\\u003C 0.01 IU\u002FmL (or FVIII:C \\\u003C 1%) or does not have a genotype predicted to cause severe hemophilia A\n* Mother or child did not have minimal required study samples or data collected before birth, around the time of delivery, or in the neonatal period\n* Child has another clinically significant bleeding disorder\n* Child has a clinically severe immune disorder\n* Participation in another study for which any blood collection total would exceed safety limits defined in this study\n* Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study",{"count":380,"type":24},"This study longitudinally observes the intergenerational (mother-child) continuum in hemophilia A from pregnancy through early childhood. Because the study follows mother-child pairs, the study includes both a maternal cohort and a pediatric cohort. Each cohort has a primary goal: for the mother with a severe hemophilia genotype, the overarching primary goal is to understand the risks for pregnancy-associated bleeding and postpartum hemorrhage (PPH); for the child, the overarching primary goal is to understand the risks, timing, and circumstances of development of anti-FVIII antibodies. From a longitudinal perspective, risks for both bleeding in the mother and anti-FVIII antibody development in the child are expected to be influenced over time by genetic and environmental factors that begin early in (or before) pregnancy. Enrollment of blood relatives is offered to improve power to better understand inherited contributions to bleeding and inhibitor development in the mother-baby pairs.",[719,720,721,722,723,724,70,725,32,726,727,728,729],"Hemophilia A","Hemophilia A, Severe","Factor VIII (FVIII)","FVIII Deficiency","Carrier of Hemophilia A","Inhibitors","Maternal Blood Loss","Bleeding Disorder","Hemorrhage, Postpartum","Alloimmunization","X-Linked",[70,731,732,726,733,734,719,735,736,737,738],"Inhibitor","Bleeding","Maternal Child Health","Hemophilia","Hemophilia A Carrier","Hemophilia A Symptomatic Carrier","Coagulation","Factor VIII","2026-02-09",{"date":741,"type":37},"2026-02-17",{"date":743,"type":37},"2024-07-31",{"date":745,"type":24},"2029-08",{"name":747,"class":44},"University of Washington"]