Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion in Women With Previous Caesarian Section: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Induction-to-abortion interval time.
研究概览
简要总结
The aim of this work is to assess the effectiveness and safety of Ulipristal Acetate in the management of 2nd trimester missed abortion along with misoprostol in pregnant women with previous caesarean section versus the use of misoprostol only with placebo as regards the time needed for abortion,Hypothesis: In pregnant women with 2nd trimester missed abortion with previous caesarean section , Ulipristal Acetate may decrease the time interval to achieve abortion when combined with Misoprostol in comparison to misoprostol alone.the included women divided to 2 groups Group A: will receive Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017.Group B: will receive placebo then 12 hours later start misoprostol 100µg every 6 hours buccal according to FIGO guidelines 2017. then we assess Induction-to-abortion interval time.
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 (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with 2nd trimester missed abortions
- •Gestational age 13-26 weeks.
- •Women with a previous caesarian section scar,(para 1cs till para 4 cs).
- •Women counseled and chose medication abortion rather than surgical evacuation
排除标准
- •Women with an accompanying medical disorder such as: Preeclampsia, Diabetes Mellitus or Heart disease.
- •Primigravida women or non scarred uterus.
- •Women with previous myomectomy or hysterotomy scar or upper segment caesarean section scar.
- •Induction of abortion in women with congenital fetal malformations or positive fetal pulsations due to medical disorder.
- •Women with placenta previa .
- •Allergy or contraindications to either Ulipristal acetate or Misoprostol.
- •Women with inevitable abortion in the form of vaginal bleeding or uterine contractions
研究组 & 干预措施
ulipristal group
received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017,Then women had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy
干预措施: Ulipristal Acetate (Drug)
ulipristal group
received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017,Then women had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy
干预措施: Misoprostol (Drug)
placebo
received placebo tablet of same shape , texture of that of ulipristal then 12 hours later start misoprostol 100µg every 6 hours buccal according to FIGO guidelines 2017. Then women in had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy
干预措施: Misoprostol (Drug)
结局指标
主要结局
Induction-to-abortion interval time.
时间窗: 2 weeks
calculate the time needed from start of intervention till abortion occured
次要结局
- need for hysterotomy(2 weeks)
- complete evacuation between both groups(2 weeks)
研究者
Sarah Safwat
lecturer of obstetrics and gynaecology
Ain Shams University