Different Methods of Termination of Second Trimester Abortion: Comparative Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- complete evacuation of uterus
研究概览
简要总结
The Patient are divided into 3 groups group 1 included 50 cases using misoprostol only. group 2 included also 50 cases in which using misoprostol with letrozole. Group3 included also 50 cases in which using misoprostol with Foleys catheter for termination of second trimesteric abortion between 14 and 24 weeks
详细描述
Pregnant women were randomized into three equal groups: Group allocation was blindly randomized concealed by placement in numbered opaque sealed envelopes. These envelopes were kept in the labor ward and drawn in consecutive order:
Group 'A" (misoprostol only group): Pharmacological method for termination of second trimester missed abortion was done by given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses.
Group 'B'(misoprostol with letrozole group): The anti-estrogen action of letrozole has been show to be useful in pretreatment for termination of pregnancy ,in combination with misoprostol,women in the letrozole group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses.
Group 'C' (misoprotol with Foley's catheter group): Mechanical method for termination of second trimester missed abortion was done using the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses.
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
- •singleton pregnancy
- •gestational age between 14 and 24 weeks
- •Fetal death was confirmed by ultrasonic scan
- •Unfavorable cervix using Bishop score for cervical assessment with score less than 5
- •Parity less than 5
- •No uterine contractions
排除标准
- •Previous uterine scar eg scar for cessarian section
- •Rupture of membranes
- •Chorioamnionitis
- •Placenta previa or low lying placenta.
- •Women with medical disease like DM, coagulopathy or genital infections.
- •Hypersensitivity or contraindications for receiving misoprostol, including:Maternal asthma.Sickle cell disease.Known hypersensitivity to prostaglandins.History of glaucoma
研究组 & 干预措施
misoprostol only group
given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses
干预措施: Misoprostol (Drug)
misoprostol with letrozole group
group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses
干预措施: Misoprostol (Drug)
misoprostol with letrozole group
group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses
干预措施: Letrozole (Drug)
misoprotol with Foley's catheter group
the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses
干预措施: Misoprostol (Drug)
misoprotol with Foley's catheter group
the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses
干预措施: Foley's catheter (Procedure)
结局指标
主要结局
complete evacuation of uterus
时间窗: 24 hours after treatment
clear endometrial line \< 4 mm in thickness
次要结局
未报告次要终点