Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection
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 first trimester missed miscarriage.
详细描述
In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first 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
- Single (Outcomes Assessor)
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.
- •The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy
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 presentation.
- •Known allergy to misoprostol.
研究组 & 干预措施
sublingual misoprostol
Group A (100 patients): will be treated with sublingual misoprostol
干预措施: sublingual misoprostol (Drug)
vaginal misoprostol
Group B (100 patients): will be treated with vaginal misoprostol
干预措施: vaginal misoprostol (Drug)
结局指标
主要结局
Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection
时间窗: 7 days
次要结局
- Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm(7 days)
- Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.(7 days)
- Pain resulting from the procedure(7 days)
- Bleeding pattern following treatment(7 days)
- Additional uterotonic used(7 days)
研究者
Ahmed Abdel Shafy El Shahawy
Lecturer
Ain Shams University