Comparison of Outcome of Pregnant Females with Polycystic Ovarian Syndrome with or Without Glucophage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Rate of early pregnancy loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard Care (Diet and Exercise Only) (Procedure)
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.
干预措施: Metformin (Glucophage) (Procedure)
结局指标
主要结局
Rate of early pregnancy loss
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Amina Waheed
Post Graduate Resident
University of Health Sciences Lahore