Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester 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 sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.
详细描述
the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
a double-blind randomized controlled trial
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
- •Less than 12 weeks of gestation.
- •Pregnancy is confirmed by 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
misoprostol 400 mcg
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 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 (2 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: misoprostol 400 mcg (Drug)
misoprostol 800 mcg
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: misoprostol 800 mcg (Drug)
结局指标
主要结局
Completeness of abortion
时间窗: 7 days
Number of Participants with expulsion of Products of conception by visual inspection
次要结局
- Successful medical abortion(7 days)
- amount of calculated blood loss following treatment(7 days)
研究者
hany farouk
Clinical Professor
Aswan University Hospital