[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618845":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":43,"locations":51,"responsibleParty":91,"collaborators":93,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":26,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":26,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Management Group","ACTIVE_COMPARATOR","This group receives standard care for conventional management of GDM identified via survey in government and private sectors. This includes monthly follow-up visits with basic lifestyle modification and counselling on dietary and physical acitivity assessed via questionnaires (PDAQ and PPAQ). Medication (insulin or oral agents like metformin) is only introduced if glycemic targets are not achieved through lifestyle modifications alone. Blood glucose monitoring is performed at a standard frequency (e.g., pre- and post-meal).",[13],"Other: Usual care",{"label":15,"type":16,"description":17,"interventionNames":18},"Intensive Management Group","EXPERIMENTAL","This group receives a standardized, intensive multidisciplinary intervention. It includes weekly telephonic monitoring, personalized low-carbohydrate\u002Fcalorie diet plans, and structured moderate and intense exercise based on their activty level. Pharmacotherapy (insulin, metformin, etc.) is initiated proactively if glucose levels are not controlled within two weeks. Enhanced fetal monitoring via frequent ultrasounds is also included to assess growth and amniotic fluid. This management involves frequent antenatal visits with pre- and post-sugar monitoring for dietary and physical therapy. Secondly, rigorous monitoring will be done using Ultrasound and repeated lab tests via a dietary and physical monthly recall questionnaire.",[19],"Combination Product: Dietary intervention + Physical Activity + Monitoring",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Dietary intervention + Physical Activity + Monitoring","Dietary modifications will follow an 1800-kilocalorie structured plan that includes breakfast, two snacks, lunch, and dinner. The plan will focus on low carbohydrate intake with restrictions on lean options. Adherence will be closely monitored, with a monthly adherence questionnaire (PDAQ) to ensure tight blood sugar control.\n\nIn terms of physical activity, a structured exercise plan will incorporate household activities, occupational tasks, and various levels of exercise, ranging from light to moderate and intense.\n\nStrict monitoring and follow-up will be conducted monthly using the Physical Activity Adherence Questionnaire (PAAQ). Secondly, short acting and long acting insulin dose and frquency will be monitored.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual care","General advice and recommendations for a low glycemic diet include a flexible and adjusted daily calorie intake, structured meals without a fixed menu. Patients should be educated about healthy choices and empowered to manage their own health.\n\nExercise recommendations should be tailored to the participant's activity level, with routine ANC counseling and no standard follow-up process.\n\nIf lifestyle modifications are ineffective in controlling glycemic levels, glucophage and human insulin R will be prescribed.",[9],[32,36,38,41],{"name":33,"affiliation":34,"role":35},"Dr Kausar Tayyab, PhD*","Institute of Basic Medical Sciences, Khyber Medical University","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":35},"Dr Rubina Nazli, PhD",{"name":39,"affiliation":40,"role":35},"Dr Arshad Hussain, PhD","Northwest General Hospital, Peshawar",{"name":42,"affiliation":34,"role":35},"Dr Ehtesham, PhD",[44,48],{"name":33,"role":45,"phone":46,"phoneExt":26,"email":47},"CONTACT","+923338645454","kausar.tayyab1234@gmail.com",{"name":37,"role":45,"phone":49,"phoneExt":26,"email":50},"+923215773696","rubinanazli44@gmail.com",[52,75],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Hayatabad Medical Complex","NOT_YET_RECRUITING","Peshawar","Khyber Pakhtunkhwa","25100","Pakistan","PK",{"type":61,"coordinates":62},"Point",[63,64],71.57849,34.008,{"lat":64,"lon":63},[67,71],{"name":68,"role":45,"phone":69,"phoneExt":26,"email":70},"Dr Rubina Akhtar, FCPS Gyne","03009339930","rubiktk@hotmail.com",{"name":72,"role":45,"phone":73,"phoneExt":26,"email":74},"Dr Rukhsana Kareem","03319278486","rukhsanakareem@mtihmc.edu.pk",{"facility":76,"status":77,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Northwest General Hospital","RECRUITING",{"type":61,"coordinates":79},[63,64],{"lat":64,"lon":63},[82,85,89],{"name":83,"role":45,"phone":84,"phoneExt":26,"email":47},"Dr Kausar Tayyab, PhD Scholar","0333864545",{"name":86,"role":45,"phone":87,"phoneExt":26,"email":88},"Dr Arshad Hussian, PhD","03312710692","Hussainadr@gmail.com",{"name":90,"role":35,"phone":26,"phoneExt":26,"email":26},"Dr Sidra Jhangir, MBBS",{"type":92,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[94,97],{"name":95,"class":96},"Northwest General Hospital and Research centre","NETWORK",{"name":53,"class":98},"OTHER_GOV","100618845","effect-of-conventional-vs-intensive-management-on-gestational-diabetes-and-maternal-fetal-outcomes-100618845",false,"NCT07336914","Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes","Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes: Randomized Controlled Trial.","Inclusion Criteria:\n\n* Maternal age between 18-45 years\n* Gestational age at enrollment 24 - 28 weeks\n* Patients having Hba1c levels less then 6%\n\nExclusion Criteria:\n\n* Patients having twin pregnancies\n* Patients having PCOS\n* Diabetes diagnosed prior to pregnancy\n* Patients having severe hypertension\n* Patients having renal diseases\n* Patients using glucose altering medications","ALL","18 Years","45 Years",{"count":110,"type":111},60,"ESTIMATED","INTERVENTIONAL",[114],"NA","This study involved two management protocols to manage diabetes in pregnancy. Sixty patients having GDM will be recruited on the basis of the OGTT and randomly allocated to two management groups. One group of patients will receive counselling and the conventional method of management. while the other group will receive a tailored diet plan and physical activity with low caloric and moderate intense exercises. Both groups will receive a dietary plan based on their sugar levels weekly basis and physical activity with pharmacotherapy to adjust their sugar levels, while the intensive group will have rigorous monitoring on a monthly basis and frequent visits with repeated lab checks. This will help us to reduce short and long-term complications with improved maternal and neonatal outcomes.",[117],"Gestational Diabetes",[119,120,121,122,123],"Gestational Diabetes Mellitus (GDM)","Intensive Management","Randomized Controlled Trial (RCT)","Glycemic Control","Maternal Health","2026-01-01",{"date":126,"type":127},"2026-01-13","ACTUAL",{"date":129,"type":127},"2025-10-01",{"date":131,"type":111},"2026-04-25",{"name":5,"class":6},2]