Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor: a Randomized Control Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Induction delivery interval i.e. Time from start of medication till delivery
研究概览
简要总结
To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.
详细描述
- There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
- Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
- Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.
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
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Single vertex presentation.
- •Gestational age > 37 weeks calculated from last menstrual period or U/S scanning.
- •Bishop score <8 .
- •Not in labor.
- •Reassuring fetal heart rate (CTG for 20 min on the day of induction).
- •Valid indication for Induction of labor.
排除标准
- •Gestational age <37 weeks.
- •Patients with rupture of membranes.
- •Previous uterine scar.
- •Fetal malpresentation.
- •Multiple pregnancy.
- •Significant antepartum hemorrhage
- •Uncontrolled DM.
- •Severe Pre-eclampsia or Eclampsia
- •If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,.....etc.
研究组 & 干预措施
Cases
A dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy.
干预措施: Misotac® Sigma Pharmaceutical Industries (Drug)
Control
Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.
干预措施: Dinoprostone 3 mg (Drug)
结局指标
主要结局
Induction delivery interval i.e. Time from start of medication till delivery
时间窗: 24 hours
次要结局
- Patients delivered vaginally within the first 24 hours(24 hours)
- Duration of 1st,2nd and 3rd stages of labor(24 hours)
- Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor(12 hours)
- Maternal complications(24 hours)
- Mode of delivery(24 hours)
- Neonatal outcome(24 hours)
研究者
Sherif Essam
assistant lecturer
Ain Shams University