To evaluate the safety and efficacy of Mifepristone with Misoprostol versus Dinoprostone gel with Misoprostol in second trimester pregnancy termination in tertiary care centre
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the safety and efficacy of Mifepristone and Misoprostol versus dinoprostone gel with Misoprostol in second trimester pregnancy termination; in terms of rate of complete abortion and induced abortion interval
研究概览
简要总结
The study focuses on evaluating second trimester pregnancy termination methods, specifically comparing the efficacy and safety of two medical regimens: Mifepristone followed by Misoprostol and Dinoprostone gel followed by Misoprostol. Abortion, defined as the termination of pregnancy before fetal viability, may be spontaneous or induced. In India, the Medical Termination of Pregnancy Act and its 2021 amendments allow abortion up to 24 weeks for specific categories and beyond that in cases of lethal fetal anomalies with medical board approval. While most abortions occur in the first trimester, 10 to 15 percentage of induced abortions globally and 12.9 percentage in India occur in the second trimester. The increase in second trimester abortions is largely attributed to improved antenatal screening techniques like ultrasound and serum tests that help detect fetal anomalies. Both surgical and medical methods are available for termination, but medical methods are preferred due to a lower risk of complications. Among medical options, prostaglandins like Misoprostol and Dinoprostone are used to induce abortion by ripening the cervix and causing uterine contractions. Misoprostol, a synthetic prostaglandin E1 analogue, is widely used due to its high efficacy, low cost, safety, and ease of storage at room temperature. Dinoprostone in gel form, is also used for labor induction and abortion. The present study evaluates the 2023 FIGO recommended protocol involving Mifepristone and Misoprostol, comparing it against Dinoprostone gel combined with Misoprostol. The primary objective is to compare the rate of complete abortion and the induction-to-abortion interval between the two drug regimens. The secondary objectives include assessing the need for surgical evacuation, uterine rupture, blood loss, sepsis, pain, and the requirement for analgesia. This randomized controlled trial will be conducted at the Department of Obstetrics and Gynecology, Belagavi Institute of Medical Sciences , Belagavi. The study population will consist of pregnant women between 13 and 24 weeks of gestation who meet the inclusion criteria and seek termination at BIMS. The study will run from March 2024 to September 2025. Participants will be randomly assigned into two groups using sequentially numbered opaque envelopes. Group 1 will receive Mifepristone followed by Misoprostol, while Group 2 will receive Dinoprostone gel followed by Misoprostol. The study aims to determine the most effective and safest combination for second-trimester pregnancy termination by analyzing outcomes across both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women between 18 to 45years seeking termination of pregnancy between 13-24 weeks of gestation fulfilling the prerequisites of Medical Termination of Pregnancy act 1971 and its amendments in 2021.
排除标准
- •Women with hemoglobin less than 8mg/dl Multiple Pregnancy Women with coagulation disorder Women with other medical disorders Incomplete abortion Patient with per vaginal leak Low lying placenta Patient with more than 1 previous cesarean section Intrauterine death Septic abortion Molar pregnancy Prior allergy to any of the drugs used in the study.
结局指标
主要结局
To evaluate the safety and efficacy of Mifepristone and Misoprostol versus dinoprostone gel with Misoprostol in second trimester pregnancy termination; in terms of rate of complete abortion and induced abortion interval
时间窗: One year
次要结局
- To compare & analyse need for surgical evacuation, uterine rupture, blood loss , sepsis, pain & need for analgesia between the study group(One year)
研究者
Dr Geetha Shree B
Belagavi institute of medical sciences
