Comparative Study Between Combined Vaginal Misoprostol With Isosorbide-5-Mononitrate Versus Misoprostol Alone For Induction Of The First Trimester Missed Abortion A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Induction to abortion interval
研究概览
简要总结
"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate
详细描述
"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial"
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Maternal Age 18 - 35 years.
- •Gestational age first trimester of pregnancy (between 5-13 weeks).
- •Missed abortion confirmed by ultrasound.
- •Singleton pregnancy.
- •Normal uterus and cervix on clinical examination.
- •Cervix is not dilated.
- •No vaginal bleeding.
排除标准
- •Evidences suggesting start of spontaneous abortion and previous trial to induce abortion.
- •Presence of uterine contraction or bleeding,
- •Multi-fetal pregnancy.
- •Suspicion of septic abortion.
- •History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization .
- •Uterine anomaly.
- •Presence of IUD( intrauterine device) in situ
- •Underlying medical diseases.Ex:diabetes mellitus,hypertension
- •History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate
- •Those unwilling to participate in the trial
- •Higher order cesarean section(more than three
研究组 & 干预措施
patients who recieve misoprostol alone
Group A (n =30 ) will receive only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or uterine contractions or bleeding assessed by the same doctor who made evaluation at the beginning.
干预措施: Misoprostol and iso sorbide mononitrates (Drug)
patients who recieve misoprostol and iso sorbide mononitrate
Group B (n =30 ) will receive combined vaginal Misoprostol 800mcg (4 tablets Cytotec ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or start of uterine contractions or bleeding. with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning with misoprostol until reaching cervical ripening or start of and uterine contractions assessed by the same doctor who made the evaluation at the beginning.
干预措施: Misoprostol and iso sorbide mononitrates (Drug)
结局指标
主要结局
Induction to abortion interval
时间窗: 6 months
Induction to abortion interval: the Duration interval between the beginning of the induction and beginning of cervical ripening assessed by cervical examination(cervix become soft and start to dilate) and uterine contractions leading to complete expulsion of the abortus spontaneous and if cervical ripening isn't occur by maximum doses the investigators will make surgical evacuation.
Number of the doses
时间窗: 6 months
the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical)
次要结局
未报告次要终点
研究者
Kholod Mohamed Mahmoud Mousa Elkholy
resident of obstetrics and gynacology
Cairo University