Health Condition 1: null- Gestational Diabetes
Conditions
Interventions
Intervention1: Metformin: Tab Metformin 500mg orally three times a day upto 2500mg/day duration will be untill delivery.
Control Intervention1: None: N/A
Control Intervention2: Insulin Therapy: Subcut
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: ?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
Exclusion criteria
Exclusion criteria: ?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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect and efficacy of Metformin on pregnancy and Achieving defined glycemic targets and comparing it with InsulinTimepoint: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for additional Insulin in achieving the glycemic targets Pregnancy complications in both the groups (Hydramnios, Macrosomia,Congenital malformations) Acceptability and satisfaction of treatment (Satisfaction score chart) Neonatal complications (Hypoglycaemia, Hyper-bilirubinemia, NICU admission Timepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Neeta Singh
All India Institute of Medical Sciences. (AIIMS)
Outcome results
None listed