Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country (migdm&t2dm)
|ClinicalTrials.gov Identifier: NCT01855763|
Recruitment Status : Unknown
Verified May 2013 by Jahan Ara Ainuddin, Dow University of Health Sciences.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2013
Last Update Posted : May 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Type 2 Diabetes Pregnancy||Drug: Metformin Drug: Insulin||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
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
- Alive baby [ Time Frame: At birth, up to 28 days after birth ]it will include alive , neonatal death and still born
- Neonatal morbidity [ Time Frame: at birth upto 28 days after birth ]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 ]
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 ]total weight gain in pregnancy in kg
- Maternal hypertensive complications [ Time Frame: day 1(study entry ) till 1 week after delivery ]it will include pregnancy induced hypertension and preeclampsia.
- treatment acceptability and cost of drug [ Time Frame: during study ]compliance and acceptability of treatment cost of metformin treatment compared with cost of insulin treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855763
|Principal Investigator:||jahanara ainuddin, MBBS, FCPS||Associate Professor Dow university of health sciences|