[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adverse-pregnancy-outcomes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adverse-pregnancy-outcomes":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,72,106,140,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100639636","the-bone-and-heart-health-consequences-of-ovarian-aging-beacon-study-100639636",false,"NCT07621965","The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study","BEACON","Inclusion Criteria:\n\n* We will include all IU study participants (n=655) for these analyses to characterize the ovarian aging trajectory of the cohort over time. The approach will allow us to move forward with the ovarian aging biomarker assays while recruitment for the in-person visit is ongoing. We will recruit a subgroup of current the IU cohort (n=352) to complete an in-person study visit at the FIT Core and Clinical Research Center. We will only recruit those who are at least 35 years old to this subgroup.\n\nExclusion Criteria:\n\n* We will exclude any potential participants who are unable to provide written informed consent in English or Spanish (the only languages allowed at the IU site for nuMoM2b), if the participant is currently pregnant, has undergone recent major surgery or sustained major injury or broken bones within 6 months of recruitment.","FEMALE",{"count":18,"type":19},655,"ESTIMATED","OBSERVATIONAL","Ovarian aging is a major driver of a woman's long-term health and disease risk. In particular, the rapid decline in the ovarian reserve that occurs with the menopause transition is linked to a striking increase in the risk for both cardiometabolic disease and osteoporosis. A growing body of evidence has demonstrated that earlier age at menopause further exacerbates this risk for ischemic stroke, heart disease, and non-traumatic osteoporotic fracture. Thus, the identification of factors that accelerate ovarian aging is likely to lead to increased incidence and earlier onset of these conditions. Adverse pregnancy outcomes (APO) such as gestational diabetes, hypertensive disorders of pregnancy, and stillbirth, are major pathophysiological states that have the potential to accelerate depletion of the ovarian reserve due to the chronic inflammatory state, oxidative stress, and epigenetics changes that ensue. This proposal seeks to determine if APOs impact the ovarian aging trajectory and subsequent cardiometabolic and musculoskeletal health outcomes. Our central hypothesis is that APOs will accelerate ovarian aging, resulting in greater incidence and earlier onset of cardiometabolic disease and musculoskeletal decline. This hypothesis will be tested by accomplishing three aims designed to: 1) define the trajectory of ovarian aging and the impact of APOs on indicators of ovarian aging over time; 2) correlate the ovarian aging trajectory with the development of cardiometabolic risk; and 3) determine the association of ovarian aging biomarker trajectory on musculoskeletal health. To accomplish these aims we will capitalize on a subset of participants from the large, multisite nuMoM2b cohort that has been followed for fifteen years since the time of their first pregnancy. This project, the Bone and hEArt health Consequences of Ovarian agiNg (BEACON) Study, will utilize the extensive health, behavior, psychosocial and pregnancy data in this cohort, paired with biospecimens from their initial pregnancy and follow-up visits (3-7 \\& 7-12 years after pregnancy), as well as data and specimens collected on participants completing an additional study visit. This proposal has the unique opportunity to provide longitudinal insight into the role of APOs in ovarian aging. If APOs are shown to accelerate ovarian aging, this mechanism may contribute to earlier onset of vascular dysfunction, metabolic disease, and musculoskeletal decline that would highlight the need for revised risk stratification for women with APOs, earlier screening (e.g., bone density, blood pressure \\& lipids), and the development of targeted prevention strategies. Moreover, these findings could identify critical windows for intervention and reveal novel targets for earlier and more effective therapeutic strategies.",[23,24],"Ovarian Aging","Adverse Pregnancy Outcomes",[26,27,28,29,30],"ovarian aging","perimenopause","menopause","cardiovascular health","musculoskeletal health","NOT_YET_RECRUITING","2026-05-27",{"date":34,"type":35},"2026-06-02","ACTUAL",{"date":37,"type":19},"2027-04-01",{"date":39,"type":19},"2032-03-30",{"name":41,"class":42},"Indiana University","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100612774","apos-associated-with-respiratory-viral-infections-before-and-during-early-pregnancy-100612774","NCT07257952","APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy","An Observational Study on the Risk of Adverse Maternal and Infant Outcomes Associated With Respiratory Viral Infections Before and During Early Pregnancy","APO","Inclusion Criteria:\n\n* Female;\n* Age 20 to 45 years old;\n* Physician-diagnosed acute respiratory viral infection occurring within 6 months before pregnancy and\u002For at \\\u003C24 weeks of gestation.\n\nExclusion Criteria:\n\n* Pregestational T1D or T2D;\n* Long-term use of immunosuppressants or glucocorticoids;\n* Diseases that severely affect immune or metabolic function (e.g., HIV, SLE, rheumatoid arthritis);\n* Severe mental illness or cognitive impairment;\n* Women whose electronic medical records lack GDM screening and delivery records.","20 Years","45 Years",{"count":54,"type":19},1440,"Adverse pregnancy outcomes (APOs) are a collection of conditions that have short-term and long-term effects of complications related to pregnancy and childbirth on pregnant women and their fetuses, including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, large for gestational age, among others. Nearly 30% of all women experience an adverse pregnancy outcome during their reproductive years. Although, respiratory viral infections with epidemic and pandemic potential pose an omnipresent threat to public health, research focusing specifically on the maternal-infant population remains relatively scarce.\n\nStudies conducted in USA found that among pregnant women infected with influenza, the proportion of those with gestational hypertension or diabetes was higher than in pregnant women without influenza infection (13.9% vs. 11.1%).\n\nResearch on the impact of respiratory viral infections on perinatal outcomes in China is limited, and we aim to establish of a large-scale, retroprospective maternal-child cohorts. This cohort study will systematically collect longitudinal data (e.g., detailed clinical history, timing of infection\u002Fvaccination, complication of pregnancy, and APOs) to assess the risk of respiratory viral infections to APOs, as well as facilitate multidisciplinary research.",[57,24],"Respiratory Viral Infections",[59,60,61,62],"Adverse pregnancy outcome","Preterm birth","Gestational diabetes mullitus","Respiratory Viral Infection","2026-04-21",{"date":65,"type":35},"2026-04-23",{"date":67,"type":19},"2026-07-05",{"date":69,"type":19},"2028-11-30",{"name":71,"class":42},"Shanghai General Hospital, China",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100583648","lifestyle-education-activity-nutrition-lean-into-pregnancy-100583648","NCT06879054","Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy","Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy: A Randomized Controlled Trial Investigating the Impact of Healthy Lifestyle Education During Preconception and Early Pregnancy on Cardiovascular and Pregnancy Outcomes","LEAN","Inclusion Criteria:\n\n* Patients in a period of preconception who want to become pregnant within 2 years, or patients in their first trimester of pregnancy\n* English-speaking\n* At risk for preeclampsia based on the following ACOG criteria: ≥1 high-risk factor: history of preeclampsia, multifetal gestation, chronic hypertension, gestational hypertension, pregestational diabetes, renal disease, or autoimmune disease, OR ≥2 moderate-risk factors: nulliparity, obesity (BMI\\>30 kg\u002Fm2), family history of preeclampsia, Black or African American race, age ≥35 years, or personal history factors (previous pregnancy low birth weight, previous stillbirth, previous preterm birth, \\>10-year pregnancy interval).\n* At risk for gestational diabetes, defined by ACOG as a BMI \\> 25 plus one or more of the following risk factors: physical inactivity, first-degree relative with diabetes, high-risk race\u002Fethnicity (African American, Latino, Native American, Asian American, Pacific Islander), previous infant weight \\>4,000g, previous GDM, chronic hypertension, HDL \\\u003C35, triglyceride \\>250, PCOS, A1c ≥ 5.7, prepregnancy BMI \\>40.\n\nExclusion Criteria:\n\n* No access to a smartphone\n* Major fetal anomaly diagnosed during current pregnancy, if pregnant at consent","18 Years","35 Years",{"count":83,"type":19},200,"INTERVENTIONAL",[86],"NA","The goal of this randomized controlled clinical trial is to determine if healthy lifestyle education can help improve cardiovascular health and reduce pregnancy complications in women during the preconception period or early pregnancy. The main aims include:\n\n1. Determine the feasibility and acceptability of the LEAN into pregnancy study.\n2. Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular health score.\n3. Determine the impact of health lifestyle education on adverse pregnancy outcomes, specifically gestational diabetes and preeclampsia.\n\nA total of 200 participants will be randomly assigned to receive healthy lifestyle education in addition to routine care, or routine care alone. Participants will be asked to participate in the following activities:\n\n* Blood draws to test hemoglobin A1c and lipids\n* Surveys about diet, physical activity, sleep, and tobacco use\n* Gaples Nutritional Education Modules (if applicable)",[89,90,91,24],"Pregnancy","Preconception Education","Preconception Care, Preconception Risk",[93,94,89,95],"Preconception education","Cardiovascular health","Lifestyle intervention","2026-03-11",{"date":98,"type":35},"2026-03-12",{"date":100,"type":19},"2026-07-01",{"date":102,"type":19},"2029-09",{"name":104,"class":42},"Medical College of Wisconsin",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":84,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100577465","effect-of-visual-presentation-of-atherosclerotic-plaque-on-modification-of-arterial-hypertension-one-year-postpartum-in-women-with-a-history-of-adverse-pregnancy-outcomes-and-risk-customization-with-ai-prediction-algorithms-100577465","NCT06798649","Effect of Visual Presentation of Atherosclerotic Plaque on Modification of Arterial Hypertension One Year Postpartum in Women With a History of Adverse Pregnancy Outcomes, and Risk Customization With AI Prediction Algorithms","Effect of Visual Presentation of Atherosclerotic Plaque on Modification of Arterial Hypertension One Year Postpartum in Women With a History of Adverse Pregnancy Outcomes, and Risk Customization With AI Prediction Algorithms: GESTA-COR Trial, a Prospective Randomised Clinical Trial","GESTA-COR","Inclusion Criteria:\n\n* Women aged 18 years and older.\n* History of one or more adverse pregnancy outcomes (APOs) such as preeclampsia, gestational diabetes, preterm birth before 37 weeks of gestation, or intrauterine growth restriction (fetal weight below the 10th percentile).\n\nExclusion Criteria:\n\n* Women with a history of significant cardiovascular events such as myocardial infarction, angina, stroke, heart failure, recovered sudden death, or atrial fibrillation.\n* Inability to provide informed consent.\n* Women who do not meet the specific APO criteria set out for the study.",{"count":115,"type":19},318,[86],"The GESTA-COR study is a prospective, non-commercial, randomized clinical trial designed to evaluate the impact of detailed vascular imaging feedback on the management of cardiovascular health in women with a history of adverse pregnancy outcomes (APOs). The trial aims to determine if providing these women with detailed images of their vascular status can encourage the adoption of healthier lifestyles and adherence to preventive treatments, thereby potentially reducing the incidence of postpartum hypertension and other cardiovascular diseases.\n\nThis study involves two randomized groups:\n\nIntervention Group (Randomized): Women with APOs receiving detailed vascular imaging results.\n\nStandard Management Group (Randomized): Women with APOs who will continue receiving standard health information without vascular imaging results.\n\nParticipants will be monitored for 12 months postpartum, focusing on blood pressure levels, cardiovascular health indicators, and lifestyle changes.",[24,119],"Cardiovascular Diseases",[121,122,123,124,125,126,127,128,129,130],"cardiovascular disease","vascular imaging","adverse pregnancy outocomes","preeclampsia","gestational diabetes","preterm birth","cardiovascular prevention","vascular health","clinical trial","health of women","2025-09-26",{"date":133,"type":35},"2025-09-29",{"date":135,"type":19},"2026-06-01",{"date":137,"type":19},"2029-12-31",{"name":139,"class":42},"Maternal-Infantil Vall d´Hebron Hospital",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":105},"100357614","an-observational-retrospective-cohort-study-being-conducted-in-women-with-atopic-dermatitis-ad-100357614","NCT03936335","An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)","Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)","Key Inclusion Criteria:\n\n* Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP\n* Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy\n\nNote: Other Protocol Defined Inclusion \u002F Exclusion Criteria Apply","49 Years",{"count":149,"type":19},3930,"The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion\u002Fmiscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \\[MCMs\\], small for gestational age \\[SGA\\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.",[24,152],"Atopic Dermatitis","RECRUITING","2025-07-30",{"date":156,"type":35},"2025-08-03",{"date":158,"type":35},"2019-09-30",{"date":160,"type":19},"2027-01-21",{"name":162,"class":163},"Regeneron Pharmaceuticals","INDUSTRY",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":84,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":105},"100575087","effectiveness-of-a-lifestyle-intervention-for-pregnant-women-with-abnormal-glucose-metabolism-in-early-pregnancy-eagm-trial-100575087","NCT06767722","Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial","Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial","EAGM","Inclusion Criteria:\n\n* Over 18 years of age.\n* Able to provide informed consent.\n* Confirmed viable pregnancy on a nuchal translucency scan done between 11+0 and 13+6 weeks.\n* Singleton pregnancies.\n* An abnormal glucose metabolism determined by a blood test performed before 14 weeks, defined as FPG 5.1-6.9mmol\u002FL and\u002For HbA1c 5.7-6.4%.\n\nExclusion Criteria:\n\n* Pregestational diabetes (diagnosed as diabetes mellitus before pregnancy, or FPG≥7.0mmol\u002FL, or HbA1c≥6.5% at the first prenatal visit), impaired fasting glucose or impaired glucose tolerance diagnosed before pregnancy.\n* Plan for termination of pregnancy due to fetal anomaly identified at the first trimester scan.\n* Use of medications known to interfere with glucose metabolism (e.g. corticosteroids, antipsychotic drugs) at the time of randomisation.\n* Any other physical (serious medical conditions such as cancer, organ failure, epilepsy, paraplegia, disability) or psychological condition (e.g. learning difficulties, serious mental illness) that is likely to interfere with the conduct of the trial according to evaluation by the trial monitoring group.\n* Women currently with hyperemesis gravidarum leading to dehydration or requiring hospitalization. If persisting vomiting resolves, the patient may be reassessed for inclusion in the trial up to and including 14+6 weeks of gestation, providing all other inclusion and exclusion criteria are met.","55 Years",{"count":174,"type":19},3430,[86],"This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.",[178,179,180,181,24],"Early Pregnancy","Fasting Plasma Glucose","Hemoglobin A1c Protein, Human","Lifestyle Intervention","2025-06-25",{"date":184,"type":35},"2025-07-01",{"date":186,"type":35},"2025-04-16",{"date":188,"type":19},"2027-06-30",{"name":190,"class":42},"First Affiliated Hospital, Sun Yat-Sen University"]