Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country (migdm&t2dm)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|