Clinical trial · Interventional
Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage
Comparison of Outcome of Pregnant Females with Polycystic Ovarian Syndrome with or Without Glucophage
- 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)
The goal of this clinical trial is to learn if Glucophage (metformin) improves pregnancy outcomes in women with polycystic ovarian syndrome (PCOS). It will also evaluate the safety of Glucophage during pregnancy. The main questions it aims to answer are: Does Glucophage reduce the risks of early pregnancy loss, preterm delivery, and gestational diabetes? Are there any medical problems associated with taking Glucophage during pregnancy? Researchers will compare Glucophage with standard care (diet and exercise) to see if it improves pregnancy outcomes in women with PCOS. Participants will: Take Glucophage or follow a standard diet and exercise plan throughout pregnancy. Attend regular follow-up visits for checkups, ultrasounds, and blood tests. Have their pregnancy outcomes, such as fetal growth and gestational diabetes, recorded.
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 |
|---|---|---|---|
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
| Pregnancy Outcomes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin (Glucophage) | Procedure | — | UNRESOLVED |
| Standard Care (Diet and Exercise Only) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Glucophage Treatment Group
- description
- In this arm, participants will receive a standard diet and exercise plan along with Glucophage (metformin). Metformin will be administered starting at 500 mg daily and gradually increased to 1500 mg daily for non-obese participants and 2000 mg daily for obese participants, starting from the second week of pregnancy until delivery. The goal is to evaluate the effectiveness of Glucophage in improving pregnancy outcomes for women with PCOS, including reducing early pregnancy loss, preterm delivery, gestational diabetes, and intrauterine growth restriction.
- interventionNames
- Procedure: Metformin (Glucophage)
- type
- ACTIVE_COMPARATOR
- label
- Standard Care Group:
- description
- Participants in this arm will receive a standard diet and exercise plan but will not receive any pharmacological intervention. This group will serve as a comparison to assess the impact of Glucophage on pregnancy outcomes in women with PCOS. All participants will be closely monitored throughout the pregnancy with regular follow-up visits and ultrasounds.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: Pregnant females aged 18-40 years Diagnosed with polycystic ovarian syndrome (PCOS) before conception, as per operational definition. Present in the 1st trimester at the booking visit. Singleton fetus on booking scan between 5th to 13th week of gestation. Exclusion Criteria: Females who do not give informed consent for follow-up. Females with preeclampsia (BP ≥140/90 mmHg with proteinuria \>+1 on dipstick method). Females already diagnosed with gestational diabetes (OGTT \>186 mg/dl). Females already taking trial treatment (as per medical record). Twin pregnancy or abnormal placenta (assessed on ultrasound). Diagnosed hypertensives and diabetic patients.
References
Publications (0)
Data not yet available