Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Completeness of abortion
研究概览
简要总结
The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage
详细描述
In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.
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
盲法说明
an open-label randomized controlled study
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
- •All women above 18 years of age
- •between 13-26 weeks of gestation.
- •Pregnancy is confirmed by a pregnancy test or ultrasound scan.
- •missed abortion
- •Normal general and gynecological examination.
排除标准
- •Hemodynamically unstable.
- •Suspected sepsis with temperature 38 °C.
- •Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
- •respiratory illnesses, recent liver disease, or pruritus of pregnancy.
- •Presence of intrauterine contraceptive device (IUCD).
- •Suspect or proven ectopic pregnancy.
- •-Failed medical or surgical evacuation before the presentation.
- •Known allergy to misoprostol.
研究组 & 干预措施
sublingual misoprostol
All patients will receive three doses of sublingual misoprostol every four hours. The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
干预措施: sublingual misoprostol (Drug)
vaginal misoprostol
All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Paracetamol, eight hourly, will be provided as analgesic or antipyretic
干预措施: vaginal misoprostol (Drug)
结局指标
主要结局
Completeness of abortion
时间窗: 7 days
expulsion of Products of conception by visual inspection
次要结局
- Successful medical abortion(7 days)
- Bleeding pattern following treatment(7 days)
研究者
hany farouk
A Professor
Aswan University Hospital