Clinical trial · Interventional
Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome
Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )
NCT02802215CI-TRIAL-00022606MGDPCOSunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the development of gestational diabetes(GDM) and improving pregnancy outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes, Gestational | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin | Drug | Metformin | ALIAS |
| placebo (folic acid ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin group
- description
- 40 women will receive metformin in dose of 1500 mg per day orally (500 mg every 8 hrs in the middle of meal) starting from 12th week of gestation till delivery.
- interventionNames
- Drug: metformin
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- 40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.
- interventionNames
- Drug: placebo (folic acid )
Primary outcomes (1)
- measure
- Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * All women had confirmed diagnosis of PCOS before pregnancy according to revised 2003 Rotterdam criteria. * Age more than 20 and more than 40 years. * BMI ranging from (25\_35 ) * Written and signed informed consent is given from the patient to participate in the study. Exclusion Criteria: * Women with pre-gestational diabetes mellitus confirmed by 2hrs OGTT. * Patients who take metformin in the first 12 wk of pregnancy. * Patients who are unwilling to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.