Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus: A Randomized Comparative Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Induction-to-abortion interval time.
研究概览
简要总结
The goal of this clinical trial is to compare the induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus. The main question it aims to answer is:
• Is the usage of laminaria japonicum as a mechanical dilator for the cervix followed by Prostaglandin E1 more effective and time saving than using prostaglandin E1 alone in induction of mid-trimester abortion in a previously scarred uterus? Researchers will compare induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus.
Participants in Group A: induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
Participants in Group B: induction of abortion will be carried out by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range 18-45 years old.
- •Women with previous scarred uterus.
- •Presence of an indication for induction of abortion.
- •Estimated gestational age between 13-26 weeks as calculated from last normal menstrual period (LMP) and confirmed by abdominal ultrasound.
排除标准
- •Primigravida women.
- •Pregnant women with placenta previa accreta spectrum.
- •Women with diagnosed cervical cancer.
- •History of cervical surgery or presence of cervical scarring.
- •Presence of allergy to any of the used drugs in the study.
- •Women withdraws or declines to participate in this study.
研究组 & 干预措施
Laminaria japonicum to be followed by Misoprostol
Induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
干预措施: Misoprostol ( Cytotec) 200 microgram a tablet (Drug)
Laminaria japonicum to be followed by Misoprostol
Induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
干预措施: Laminaria Tent (Drug)
Misoprostol only
Induction of abortion will be carried out only by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
干预措施: Misoprostol ( Cytotec) 200 microgram a tablet (Drug)
结局指标
主要结局
Induction-to-abortion interval time.
时间窗: From enrollment to the end of abortion, an average of one week
Time taken from the start of induction of abortion till occurrence of abortion
次要结局
- Rate of Operative intervention(From enrollment to the end of abortion, an average of one week)
- Amount of vaginal bleeding(From enrollment to the end of abortion, an average of one week)
- Rate of occurrence of uterine rupture followed by hysterectomy(From enrollment to the end of abortion, an average of one week)
- The amount of Misoprostol doses needed (microgram)(Group A: after removal of Laminaria till expulsion of the fetus, an average of one week while for Group B: From enrollment to the end of abortion, an average of one week)
研究者
Pavly Maged Jimmy Fouad
Assistant Lecturer of Obstetrics and Gynecology at Ain Shams University
Ain Shams Maternity Hospital