Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- induction abortion interval
研究概览
简要总结
the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.
the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.
详细描述
the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.
In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.
The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.
The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.
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
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 16 -40 years
- •Missed abortion
- •Singelton pregnancy
- •Gestationl age between 13 and 26 weeks of pregnancy
- •Normal uterus and cevix on clinical examination
- •Cervix is not dilatated
- •No uterine activity and vaginal bleeding
- •Written and informed consent by the patient
- •Unscarred uterus
排除标准
- •Presence of uterine contraction or bleeding
- •Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
- •Multifetal pregnancy
- •Suspicion of septic abortion
- •History of cervical surgery or manipulation
- •Uterine anomaly
- •IUD in situ
- •Associtaed hemorrhagic disorder
- •History of adverse effects to vaginally adminstered medication
- •Inability to insert vaginal medication high in vagina
研究组 & 干预措施
study group
misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once
干预措施: Misoprostol (Drug)
study group
misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once
干预措施: isosorbide mononitrate (Drug)
control group
misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo
干预措施: Misoprostol (Drug)
control group
misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
induction abortion interval
时间窗: 24 hours
time needed to induce abortion in second trimester abortion
次要结局
未报告次要终点
研究者
Mohamed abd elfatah elsenity
lecturer MD
Ain Shams University