Results seen in pregnant women treated with metformin in early stages of pregnancy when glucose levels tested 2 hours after meal are raised above normal level
Phase 2
- Registration Number
- CTRI/2024/07/071360
- Lead Sponsor
- Srilekha Thupili
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Pregnant women with period of gestation less than 9 week having gestational glucose intolerance with PPBS more than 110 mg/dl
Exclusion Criteria
1) women with pre-existing diabetes mellitus
2)women with pcos on metformin therapy
3)women who are having bleeding or pain abdomen
4) women who are known case of chronic medical disorder such as hypertension,chronic liver disease ,cardiovascular diseases
5) active infections like TB,HIV,Malaria,other febrile illness
6) Multiple pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare proportion of women with early gestational intolerance who develop gestational intolerance or gestational diabetes in medical nutrition therapy versus metformin and medical nutrition therapyTimepoint: 8 to 9 weeks,11 to 12 weeks,14 to 16 weeks,24 to 28 weeks,32 to 34 weeks
- Secondary Outcome Measures
Name Time Method Foetal & maternal complications <br/ ><br>Foetal outcome includes LGA,FGR,preterm,subcutaneous thickness,ponderal index,proportion of newborn with admission in nursery or NICU,still birth,early neonatal deaths <br/ ><br>Maternal outcomes include hypertension,cesarean delivery,polyhydromnios,shoulder dystocia,weight gain during pregnancyTimepoint: 37 to 40 weeks of gestation age