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NCT Number: NCT06713967

Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and 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.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Pregnancy Outcomes Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin (Glucophage)

Procedure

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.

Standard Care (Diet and Exercise Only)

Procedure

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amina Waheed, MS (OBSTETRICS & GYNAECOLOGY)

CONTACT

[email protected]

0331-6138096

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Dec 3, 2024
Registry last updated: Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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