[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582788":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":79,"studyPopulation":72,"armGroups":80,"interventions":91,"overallOfficials":96,"centralContacts":72,"locations":101,"responsibleParty":128,"collaborators":72,"id":131,"slug":72,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":72,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":72,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":104,"whyStopped":72,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Eastern Virginia Medical School","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":72},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Need for GDM Medication","The primary outcome is the need for medication (either insulin or oral hypoglycemic agents) for management of gestational diabetes (progression from GDMA1 to GDMA2). We chose this primary outcome because the need for medication is associated with the need for significantly more antenatal interventions due to increased adverse pregnancy outcomes.","From date of randomization until the date of first documented progression (assessed up to 7 months)",[14,18,22,25,28,31,34,37,40,43,46,50,53,56,59,62,65,68],{"measure":15,"description":16,"timeFrame":17},"Hgb A1c at delivery","Measurement of Hgb A1c","At delivery",{"measure":19,"description":20,"timeFrame":21},"Rate of Fetal Demise","Rate of fetal demise","From date of randomization until the date of documented occurrence (assessed up to 7 months)",{"measure":23,"description":24,"timeFrame":12},"Number of Participants Diagnosed with Fetal Growth Restriction","Number of participants diagnosed with fetal growth restriction",{"measure":26,"description":27,"timeFrame":12},"Number of Participants Diagnosed with Preeclampsia","Number of participants diagnosed with preeclampsia",{"measure":29,"description":30,"timeFrame":12},"Number of Participants with Placental Abruption","Number of participants with placental abruption",{"measure":32,"description":33,"timeFrame":17},"Mode of Delivery","Rates of cesarean and vaginal deliveries",{"measure":35,"description":36,"timeFrame":17},"Indication for Cesarean Delivery","Rates of each indication for cesarean delivery",{"measure":38,"description":39,"timeFrame":17},"Rate of Shoulder Dystocia","Rate of shoulder dystocia",{"measure":41,"description":42,"timeFrame":17},"Quantitative Blood Loss","Blood loss in mL",{"measure":44,"description":45,"timeFrame":17},"Rate of Postpartum Hemorrhage","Rates of patients with quantitative blood loss \\> 1000mL",{"measure":47,"description":48,"timeFrame":49},"Rates of Infection","Rates of infection","Delivery until discharge (assessed up to 5 days)",{"measure":51,"description":52,"timeFrame":17},"Birth Weight","Birth weight",{"measure":54,"description":55,"timeFrame":17},"Apgar Score","Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome",{"measure":57,"description":58,"timeFrame":49},"Rates of Neonatal Infections","Rates of neonatal infections",{"measure":60,"description":61,"timeFrame":17},"Rate of Respiratory Distress Syndrome","Rate of respiratory distress syndrome",{"measure":63,"description":64,"timeFrame":49},"Rate of Necrotizing Enterocolitis","Rate of necrotizing enterocolitis",{"measure":66,"description":67,"timeFrame":49},"Rate of NICU Admission","Rate of admission to NICU",{"measure":69,"description":70,"timeFrame":71},"Days in NICU","Days spent in NICU","Delivery until discharge of the neonate (assessed up to 180 days)",null,{"allocation":74,"interventionModel":75,"interventionModelDescription":72,"primaryPurpose":76,"observationalModel":72,"timePerspective":72,"maskingInfo":77},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":78,"maskingDescription":72,"whoMasked":72},"NONE","The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Fiber","EXPERIMENTAL","Participants will psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.",[86],"Dietary Supplement: Fiber",{"label":88,"type":89,"description":90,"interventionNames":72},"No Fiber","NO_INTERVENTION","Participants will receive no fiber supplementation capsules.",[92],{"type":93,"name":82,"description":94,"armGroupLabels":95,"otherNames":72},"DIETARY_SUPPLEMENT","Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.",[82],[97],{"name":98,"affiliation":99,"role":100},"Jerri Waller, MD","Macon & Joan Brock Virginia Health Sciences at Old Dominion University","PRINCIPAL_INVESTIGATOR",[102],{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Macon & Joan Brock Virginia Health Sciences at ODU","RECRUITING","Norfolk","Virginia","23507","United States","US",{"type":111,"coordinates":112},"Point",[113,114],-76.28522,36.84681,{"lat":114,"lon":113},[117,122,125,126],{"name":118,"role":119,"phone":120,"phoneExt":72,"email":121},"Morgan Scaglione, MD","CONTACT","757-446-7900","scaglima@odu.edu",{"name":123,"role":119,"phone":120,"phoneExt":72,"email":124},"Kristin Ayers, MPH","ayerskl@odu.edu",{"name":98,"role":100,"phone":72,"phoneExt":72,"email":72},{"name":118,"role":127,"phone":72,"phoneExt":72,"email":72},"SUB_INVESTIGATOR",{"type":100,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":72,"oldOrganization":72},"Jerri Waller","Principal Investigator","100582788",false,"NCT06867861","Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes","Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Singleton gestation\n* Known or new diagnosis of gestational diabetes without reason for medication\n* Age \\>=18 to \\\u003C=50\n\nExclusion Criteria:\n\n* \\- Non-English as primary language.\n* Known or suspected fetal anomaly or aneuploidy.\n* Known lower bowel disorder\n* Known phenylketonuria\n* Prisoners.\n* Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.","FEMALE","18 Years","50 Years",{"count":141,"type":142},110,"ESTIMATED","INTERVENTIONAL",[145],"NA","The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.",[148],"Gestational Diabetes Mellitus (GDM)",[150,82,151],"Gestational Diabetes Mellitus","GDM","2025-03-05",{"date":154,"type":155},"2025-03-10","ACTUAL",{"date":157,"type":155},"2025-02-24",{"date":159,"type":142},"2026-08-26",{"name":5,"class":6},1]