Outcome of Patient Empowerment in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial

Status: Completed
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 35
Healthy Volunteers: f
View:

• Screen positive GDM cases, who have not been managed for diabetes by any means

• Gestational age from18 weeks to 36 weeks

Locations
Other Locations
Bangladesh
Azimpur Maternity hospital ( MCHTI)
Dhaka
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka
Shaheed Suhrawardy Medical College (ShSMC)
Dhaka
Time Frame
Start Date: 2023-01-31
Completion Date: 2024-11-10
Participants
Target number of participants: 459
Treatments
Experimental: Patient Empowerment Model
Patients will be empowered to manage gestational diabetes mellitus themselves by acquiring knowledge and skill to monitor blood sugar levels, adjusting meals and daily activities.
No_intervention: Standard of care
Patients will get the conventional way of management where patients get advice about a diet chart with a fixed menu and injection of insulin to control blood sugar levels.
Sponsors
Leads: Public Health Foundation of Bangladesh

This content was sourced from clinicaltrials.gov