protocolSection identificationModule nctId: NCT06277258, orgStudyIdInfo id: BSMMU/2022/9656, briefTitle: Patient Empowerment in the Management of Gestational Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-31, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Public Health Foundation of Bangladesh, class: OTHER, descriptionModule briefSummary: This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person., conditionsModule conditions: Diabetes Mellitus in Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: At the end of the study, the outcome will be assessed by blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 388, type: ESTIMATED, armsInterventionsModule interventions name: Patient Empowerment model, outcomesModule primaryOutcomes measure: Number of Participants with adverse maternal pregnancy outcome, primaryOutcomes measure: Number of Participants with adverse foetal outcome, primaryOutcomes measure: Number of Participants with adequate glycaemic control, secondaryOutcomes measure: Maternal satisfaction, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Azimpur Maternity hospital ( MCHTI), status: RECRUITING, city: Dhaka, zip: 1205, country: Bangladesh, contacts name: Rukhsana Parvin, MSc, role: CONTACT, phone: +8801303701545, email: rukhsana.nipa44@gmail.com, geoPoint lat: 23.7104, lon: 90.40744, locations facility: Shaheed Suhrawardy Medical College (ShSMC), status: RECRUITING, city: Dhaka, zip: 1207, country: Bangladesh, contacts name: Farhana Akter, MSc, role: CONTACT, phone: +8801819138421, email: isha.farhana19@gmail.com, contacts name: Fatema Ashraf, MBBS, FCPS, MS,MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.7104, lon: 90.40744, locations facility: Bangabandhu Sheikh Mujib Medical University (BSMMU), status: RECRUITING, city: Dhaka, zip: 1217, country: Bangladesh, contacts name: Naznin Akter, MSc, role: CONTACT, phone: +8801739867303, email: zshela286@gmail.com, contacts name: Tabassum Parvin, MBBS, FCPS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False