Comparing Metformin and Insulin for managemnt of Blood Sugars and Pregnancy related Outcomes in the mother and Baby in women with Gestational Diabetes.
Phase 3
Not yet recruiting
- Conditions
- Health Condition 1: O244- Gestational diabetes mellitus
- Registration Number
- CTRI/2024/05/066888
- Lead Sponsor
- Dr Mrunalini Patil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Pregnant woman with diagnosed gestational diabetes (according to IADPSG criteria) needing pharmacological intervention/ anti-diabetic drugs.
2. Singleton pregnancy
3. 18 to 45 years of age
4. Gestational age of 14 to 35 weeks
Exclusion Criteria
1. k/c/o diabetes mellitus
2. Chronic gastrointestinal disease
3. Women with gestational diabetes controlled on diet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Maternal outcomes like mode of delivery, association with other obstetrical disorders(like gestational hypertension, pre term delivery, etc), conversion to overt DM, etc <br/ ><br> <br/ ><br>2. Perinatal outcomes like birth weight, congenital anomalies, neonatal hypoglycemia, Jaundice, respiratory distress, NICU admission, etcTimepoint: During pregnancy, at delivery and postpartum.
- Secondary Outcome Measures
Name Time Method Glycemic control <br/ ><br>Safety profile <br/ ><br>Conversion to overt DMTimepoint: From starting of pharmacotherapy in pregnancy until 6 weeks post partum