nctId: NCT06277258 id: BSMMU/2022/9656 briefTitle: Patient Empowerment in the Management of Gestational Diabetes Mellitus overallStatus: RECRUITING date: 2023-01-31 date: 2024-10 date: 2024-12 date: 2024-02-26 date: 2024-02-26 name: Public Health Foundation of Bangladesh class: OTHER 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. conditions: Diabetes Mellitus in Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: At the end of the study, the outcome will be assessed by blinded. whoMasked: OUTCOMES_ASSESSOR count: 388 type: ESTIMATED name: Patient Empowerment model measure: Number of Participants with adverse maternal pregnancy outcome measure: Number of Participants with adverse foetal outcome measure: Number of Participants with adequate glycaemic control measure: Maternal satisfaction sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Azimpur Maternity hospital ( MCHTI) status: RECRUITING city: Dhaka zip: 1205 country: Bangladesh name: Rukhsana Parvin, MSc role: CONTACT phone: +8801303701545 email: rukhsana.nipa44@gmail.com lat: 23.7104 lon: 90.40744 facility: Shaheed Suhrawardy Medical College (ShSMC) status: RECRUITING city: Dhaka zip: 1207 country: Bangladesh name: Farhana Akter, MSc role: CONTACT phone: +8801819138421 email: isha.farhana19@gmail.com name: Fatema Ashraf, MBBS, FCPS, MS,MPH role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 facility: Bangabandhu Sheikh Mujib Medical University (BSMMU) status: RECRUITING city: Dhaka zip: 1217 country: Bangladesh name: Naznin Akter, MSc role: CONTACT phone: +8801739867303 email: zshela286@gmail.com name: Tabassum Parvin, MBBS, FCPS role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False