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

December 3, 2024 updated by: Dr. Amina Waheed, University of Health Sciences Lahore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucophage Treatment Group
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.
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.
Active Comparator: Standard Care Group:
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of early pregnancy loss
Time Frame: 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.
From enrollment to 24 weeks of gestation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 2, 2025

Primary Completion (Estimated)

May 25, 2025

Study Completion (Estimated)

May 26, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exp126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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