Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country (migdm&t2dm)
The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.
Type 2 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country|
- Alive baby [ Time Frame: At birth, up to 28 days after birth ] [ Designated as safety issue: Yes ]it will include alive , neonatal death and still born
- Neonatal morbidity [ Time Frame: at birth upto 28 days after birth ] [ Designated as safety issue: Yes ]it will include birth weight, macrosomia,neonatal hypoglycemia,transient tachypnoea of newborn ,respiratory distress syndrome,neonatal intensive care admissions, prematurity,sepsis,neonatal jaundice,birth trauma.
- glycemic control [ Time Frame: day1 (study entry ) till devlivery ] [ Designated as safety issue: Yes ]
fasting and random blood glucose levels , at study entry ,mean levels throughout pregnancy and at 36/37 weeks of pregnancy.
HbA1 C Levels,at study entry and at 36/37 weeks of pregnancy
- weight gain in prenancy [ Time Frame: day 1 (study entry) till delivery ] [ Designated as safety issue: No ]total weight gain in pregnancy in kg
- Maternal hypertensive complications [ Time Frame: day 1(study entry ) till 1 week after delivery ] [ Designated as safety issue: Yes ]it will include pregnancy induced hypertension and preeclampsia.
- treatment acceptability and cost of drug [ Time Frame: during study ] [ Designated as safety issue: No ]compliance and acceptability of treatment cost of metformin treatment compared with cost of insulin treatment
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
group A1:Consists of patients with GDM who were given drug metformin as treatment group B1:Consists of patients with type 2 diabetes in pregnancy were given the drug metformin as treatment intervention with drug metformin is given for control of diabetes in esclation dose of 500mg /day upto 2.5 grams per day in two to three divided doses till delivery
Active Comparator: insulin
GroupA2:gestational diabetes on insulin treatment Group B2:type 2 diabetes on insulin treatment intervention:insulin treatment till delivery
Other Name: humulin insulin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01855763
|Principal Investigator:||jahanara ainuddin, MBBS, FCPS||Associate Professor Dow university of health sciences|