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Clinical Trial Details

Trial ID: L3240
Source ID: NCT01855763
Associated Drug: Metformin
Title: Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country
Acronym: migdm&t2dm
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Gestational Diabetes|Type 2 Diabetes|Pregnancy
Interventions: DRUG: Metformin|DRUG: Insulin
Outcome Measures: Primary: Alive baby, it will include alive , neonatal death and still born, At birth, up to 28 days after birth|Neonatal morbidity, 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., at birth upto 28 days after birth | Secondary: glycemic control, 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, day1 (study entry ) till devlivery|weight gain in prenancy, total weight gain in pregnancy in kg, day 1 (study entry) till delivery|Maternal hypertensive complications, it will include pregnancy induced hypertension and preeclampsia., day 1(study entry ) till 1 week after delivery | Other: treatment acceptability and cost of drug, compliance and acceptability of treatment cost of metformin treatment compared with cost of insulin treatment, during study
Sponsor/Collaborators: Sponsor: Dow University of Health Sciences
Gender: FEMALE
Age: ADULT
Phases: PHASE2|PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-12
Completion Date: 2013-12
Results First Posted:
Last Update Posted: 2013-05-16
Locations:
URL: https://clinicaltrials.gov/show/NCT01855763