Use Of Hyoscine as An Adjuvant Treatment on Shortening the Time of Abortion Induction in Second Trimester: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of hyoscine as an adjuvant treatment in second trimester abortion
研究概览
简要总结
To compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
详细描述
The study will be conducted on 40 women who will undergo induction of abortion between 13-24 weeks with positive fetal pulsation. They will be randomly assigned to receive either only misoprostol 400 μg under the generic name of misotac tablets produced by Sigma company according to FIGO classification 2019 and a halved dose if the patient has a history of one or two cesarean sections, or misoprostol 400 μg plus intramuscular administration of hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Abortion between 13-24 weeks with positive fetal pulsation due to congenital fetal malformations, severe preeclampsia, and maternal life-threatening conditions.
- •Women have up to two cesarean sections.
排除标准
- •Abortion between 13-24 weeks with no fetal pulsation
- •Women who have had two or more caesarean sections.
- •Multiple pregnancies
- •Uterine anomalies, such as septate and didelphis uteri.
研究组 & 干预措施
Group 1
Intramuscular administration of 20 milligrams hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company, plus misoprostol under the generic name of misotac tablets, each of wich is 200 micrograms produced by Sigma company, approximately 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines for use of misoprostol 2019 and to have a halved dose to 200 micrograms if patient with history of one or two cesarean section.
Misoprostol only will be repeated every 4 hours for maximum 5 doses.
干预措施: hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company (Drug)
Group 1
Intramuscular administration of 20 milligrams hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company, plus misoprostol under the generic name of misotac tablets, each of wich is 200 micrograms produced by Sigma company, approximately 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines for use of misoprostol 2019 and to have a halved dose to 200 micrograms if patient with history of one or two cesarean section.
Misoprostol only will be repeated every 4 hours for maximum 5 doses.
干预措施: misoprostol under the generic name of misotac tablets (Drug)
Group 2
Administration of misoprostol under generic name of misotac tablets each one is 200 micrograms produced by Sigma company, about 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines use of misoprostol 2019 and to have a halved dose if patient with history of one or two cesarean sections.
Misoprostol only will be repeated every 4 hours for maximum 5 doses.
干预措施: misoprostol under the generic name of misotac tablets (Drug)
结局指标
主要结局
Efficacy of hyoscine as an adjuvant treatment in second trimester abortion
时间窗: Baseline
Admission Abortion interval (duration from the admission up to initiation of abortion).
次要结局
未报告次要终点
研究者
Andrew Nader Sed
Doctor
Ain Shams Maternity Hospital