[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07356180":3,"trial-entities:NCT07356180":96,"trial-summary:NCT07356180":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":39,"interventions":42,"primary_outcomes":52,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":80,"locations":82,"central_contacts":92,"overall_officials":93,"references":94,"see_also_links":95},"NCT07356180","HP-00099879","Physical Acvitiy in Pregnancy","Epigenetic Regulation of Physically Active Lifestyle on Placental Development","ENROLLING_BY_INVITATION","2027-12","2025-12","2026-01-21","2023-10-18","University of Maryland, Baltimore","OTHER",false,"The goal of this observational study is to learn how a physically active lifestyle during pregnancy affects placental development and function. The main question it aims to answer is:\n\nDoes regular physical activity during pregnancy improve placental function and support healthy fetal growth?\n\nPregnant participants will provide biological samples and health information during pregnancy and at delivery. The study will use these samples to examine how activity levels relate to placental energy production and overall health.","This observational study aims to examine how a physically active lifestyle during pregnancy affects placental function and fetal development. We will enroll pregnant participants and collect biological samples, including blood and placental tissue after delivery. The study will measure markers of placental energy production and other indicators of placental health to understand the mechanisms by which maternal physical activity may influence fetal growth.\n\nData collected will also include health information, lifestyle questionnaires, and activity assessments during pregnancy. Participants will not need to change their normal exercise habits. The results of this study may help identify how maternal physical activity supports placental and fetal health, which could inform future recommendations for healthy pregnancies.",[19,20,21,22,23],"Pregnant Women","Gestational Diabetes","Obese But Otherwise Healthy Participants","Overweight (BMI > 25)","Gestational Diabetes Mellitus in Pregnancy",[25,26,27,28,29,30,31,32,33,34,35],"maternal exercise","gestational diabetes","maternal physical activity","pregnancy","placental function","fetal development","maternal obesity","observational study","placental mitochondria","lifestyle intervention","pregnancy outcomes","OBSERVATIONAL",null,[],{"count":40,"type":41},40,"ESTIMATED",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47},"BEHAVIORAL","Pregnancy Physical Activity Questionnaire (PPAQ)","The PPAQ is a semiquantitative questionnaire that asks respondents to report the time spent participating in 32 activities including household\u002Fcaregiving (13 activities),occupational (5 activities), sports\u002Fexercise (8 activities), transportation (3 activities), and inactivity (3 activities).\n\nFor each activity, respondents are asked to select the category that best approximates the amount of time spent in that activity per day or week during the currenttrimester. Possible durations range from 0 to 6 or more hours per day and from 0 to 3 or more hours per week.",[48,49,50,51],"Con","Gestational DM group","gestational DM + overweight\u002Fobesity group","overweight\u002Fobesity group",[53],{"measure":54,"description":55,"timeFrame":56},"Placental mitochondrial function","Placental mitochondrial function will be assessed using markers of mitochondrial biogenesis and energy metabolism measured in placental tissue collected at delivery. Outcomes will be examined in relation to maternal physical activity levels during pregnancy.","At delivery",[],"FEMALE","18 Years","45 Years",{"inclusion":62,"exclusion":70,"raw_text":79},[63,64,65,66,67,68,69],"Pregnant female and their newborn infant(s)","Aged 18-45 (pregnant female), age 0-60 days of life (newborn infant)","English speaking","Screened for gestational diabetes with standard glucose tolerance test between 24w - 41w gestation","Delivered at gestational age 34week-41weeks","Delivered via non-emergent Cesarean section during weekday hours","No known infectious disease (ex: HIV, HepC)",[71,72,73,74,75,76,77,78],"Women \\\u003C18yo or \\>45yo","Non-English speaking","Pre-existing diabetes or diagnosed with diabetes prior to 24weeks","Required complex diets\u002Fsupplements not related to the pregnancy (i.e. malnutrition)","Known severe fetal anomalies or genetic disorder","Placenta accreta spectrum","Emergent cesarean delivery performed due to fetal distress","Known infectious disease (ex: HIV, HepC)","Inclusion Criteria:\n\n* Pregnant female and their newborn infant(s)\n* Aged 18-45 (pregnant female), age 0-60 days of life (newborn infant)\n* English speaking\n* Screened for gestational diabetes with standard glucose tolerance test between 24w - 41w gestation\n* Delivered at gestational age 34week-41weeks\n* Delivered via non-emergent Cesarean section during weekday hours\n* No known infectious disease (ex: HIV, HepC)\n\nExclusion Criteria:\n\n* Women \\\u003C18yo or \\>45yo\n* Non-English speaking\n* Pre-existing diabetes or diagnosed with diabetes prior to 24weeks\n* Required complex diets\u002Fsupplements not related to the pregnancy (i.e. malnutrition)\n* Known severe fetal anomalies or genetic disorder\n* Placenta accreta spectrum\n* Emergent cesarean delivery performed due to fetal distress\n* Known infectious disease (ex: HIV, HepC)",[81],"ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"University of Maryland Medical System","Baltimore","Maryland","21201","United States",{"lat":90,"lon":91},39.29038,-76.61219,[],[],[],[],{"nct_id":4,"conditions":97,"biomarkers":100},[20,98,99],"Obesity","Pregnancy",[],{"nct_id":4,"found":15,"summary":37,"prompt_version":37}]