Can oral medication replace Insulin Injections in pregnant women with Diabetes
- Conditions
- Health Condition 1: null- Gestational Diabetes
- Registration Number
- CTRI/2011/08/001956
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
?Receiving prenatal care at Department of Obstetrics and Gynaecology AIIMS New Delhi
?In the second trimester of pregnancy
?Singleton or twin pregnancy
?Able to give informed consent
?No history of Bad obstetric history (Previous two or more abortions, still births and neonatal deaths)
?No History of congenital anomalies in previous babies
?End organ complications of diabetes (retinopathy renal insufficiency etc)
?Prior adverse reaction (i e lactic acidosis) or allergy to Metformin
?liver disease
?Significant medical co-morbidities (lupus cystic fibrosis etc) Hypertension controlled on one medication well controlled asthma and well controlled thyroid diseases are not excluded.
?Bad obstetric history (Previous two or more abortions still births and neonatal deaths)
?History of congenital anomalies in previous babies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect and efficacy of Metformin on pregnancy and <br/ ><br>Achieving defined glycemic targets and comparing it with InsulinTimepoint: N/A
- Secondary Outcome Measures
Name Time Method eed for additional Insulin in achieving the glycemic targets <br/ ><br>Pregnancy complications in both the groups (Hydramnios, Macrosomia,Congenital malformations) <br/ ><br>Acceptability and satisfaction of treatment (Satisfaction score chart) <br/ ><br>Neonatal complications (Hypoglycaemia, Hyper-bilirubinemia, NICU admission <br/ ><br>Timepoint: N/A