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NOT YET RECRUITING
NCT06713967
NA

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

Sponsor: University of Health Sciences Lahore

View on ClinicalTrials.gov

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.

Official title: Comparison of Outcome of Pregnant Females with Polycystic Ovarian Syndrome with or Without Glucophage

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-02-02

Completion Date

2025-05-26

Last Updated

2024-12-06

Healthy Volunteers

No

Interventions

PROCEDURE

Metformin (Glucophage)

In this intervention, participants will receive oral metformin (500 mg daily, gradually increasing to 1500 mg daily for non-obese participants and 2000 mg daily for obese participants) starting from the second week of pregnancy and continuing until delivery. Metformin will be administered in combination with a standard diet and exercise plan. The intervention aims to evaluate the impact of metformin on pregnancy outcomes in women with polycystic ovarian syndrome (PCOS), focusing on reducing complications such as early pregnancy loss, preterm delivery, gestational diabetes, and intrauterine growth restriction. Participants will be regularly monitored with follow-up visits, ultrasounds, and glucose tests to assess the effectiveness of the treatment.

PROCEDURE

Standard Care (Diet and Exercise Only)

In this intervention, participants will receive a standard diet and exercise plan designed to promote a healthy pregnancy. This intervention does not include any pharmacological treatment, such as metformin. The goal is to evaluate the pregnancy outcomes in women with polycystic ovarian syndrome (PCOS) managed with lifestyle modifications alone, without the added effect of medication. Participants will be monitored through regular follow-up visits, ultrasounds, and glucose tests to track pregnancy progress, including the occurrence of gestational diabetes, preterm delivery, early pregnancy loss, and fetal growth restriction.