Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovarian Syndrome (PCOS); Pregnancy Outcomes

• Registration Number: NCT06713967
• Lead Sponsor: University of Health Sciences Lahore

Brief Summary

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.

Detailed Description

This randomized controlled trial aims to evaluate the effectiveness of Glucophage (metformin) in improving pregnancy outcomes for women with polycystic ovarian syndrome (PCOS). The study compares two groups: one receiving standard diet and exercise along with Glucophage and another receiving only standard diet and exercise. Outcomes such as early pregnancy loss, preterm delivery, gestational diabetes, intrauterine growth restriction, and fetal malformations will be assessed.

Participants will be enrolled during their first trimester and followed through delivery. Data will be collected during regular follow-up visits, including ultrasound scans and oral glucose tolerance tests. The study will use statistical analysis to determine whether Glucophage significantly improves maternal and fetal health outcomes compared to standard care. Findings will help guide clinical management strategies for PCOS during pregnancy.

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-27
• Status Verified: 2024-12
• Study First Posted: 2024-12-03
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Start: 2025-02-02
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of early pregnancy loss	From enrollment to 24 weeks of gestation.	The primary outcome of this study is to evaluate the rate of early pregnancy loss in pregnant women with polycystic ovarian syndrome (PCOS) who receive either Glucophage (metformin) or standard care (diet and exercise). Early pregnancy loss is defined as fetal death occurring before 24 weeks of gestation.