Oxytocin Versus Oral Misoprostol for Induction of Labor in Pregnant Women With Term Prelabor Rupture of Membranes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- vaginal delivery
研究概览
简要总结
The aim of study is to compare the efficacy and safety of oral misoprostol versus oxytocin in induction of labor in pregnant women with prelabor rupture of membranes at term.
详细描述
Type of Study: Randomized controlled clinical trial. Study Setting: The study will be conducted at Ain Shams University Maternity Hospital (ASUMH) at labor ward.
Study Population: pregnant women attending at Ain Shams University Maternity Hospital for induction of labor at term
Sample Size: The study will be conducted on (170) women; they will be subdivided into 2 groups.
- 1st group (misoprostol group): induction of labor by 25µg misoprostol oral tablet every 4 hours with maximum200 µg.
- 2nd group (oxytocin group:control group): induction of labor done by administration of oxytocin infusion according to ASUMH local protocol.
- Sample size Justification: Using PASS 11program for sample size calculation and according to (Zeteroğlu S et al, 2006), the expected mean interval from induction to delivery in misoprostol group=10.61 ± 2.45 hours and oxytocin group=11.57 ± 1.91 hours. Sample size of 85 women per group can detect the difference between two group with power80% setting alpha error at 0.05.
Study procedures and interventions:
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
- 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
- •Gestational age (36-42 weeks).
- •Prelabor rupture of membranes within the last 24hours
- •Vertex presentation
排除标准
- •History of medical diseases (HTN, diabetes milletus, systemic lupus erythematosus, cardiac, etc.).
- •Antepartum hemorrhage
- •Chorioamnionitis / prelabor rupture of membranes >24hours
- •Multiple pregnancy.
- •Abnormal fetal heart rate pattern upon admission
- •Intrauterine growth restriction
- •Fetal malpresentation.
- •Previous uterine scar.
- •Estimated fetal weight more than 4kg.
- •Patients already in labor
- •Contraindication for prostaglandin/oxytocin use (allergy,..)
研究组 & 干预措施
misoprostol group
25µg misoprostol oral tablet every 4 hours with maximum200 µg
干预措施: Misoprostol (Drug)
oxytocin group
oxytocin infusion according to ASUMH local protocol: Put 3IU oxytocin (3000mIU) +50ml of normal saline in syringe pump= (60mIU/ml). Commence at 1ml/hour (1mIU/min) for 1/2 hour.
- If contractions inadequate +fetal monitor healthy 2 ml/hour for 1/2 hour.
- If contractions inadequate +fetal monitor healthy 4 ml/hour for 1/2 hour.
- If contractions inadequate +fetal monitor healthy 6 ml/hour for 1/2 hour.
- If contractions inadequate +fetal monitor healthy increase by 2ml/hr. for max. 27ml/hour.
At any point there's fetal or maternal distress (e.g. pathological FHR pattern, antepartum hemorrhage, etc.) the study intervention will be stopped, and the maternal/fetal condition will be managed by cesarean section.
干预措施: Syntocinon (Drug)
结局指标
主要结局
vaginal delivery
时间窗: immediately after the intervention
rate of successful vaginal delivery
次要结局
- induction to active phase time(during the intervention)
- Induction to delivery time(during the intervention)
- NICU admission(within 24hours after birth)
- Apgar score(The score is reported at 1 minute and 5 minutes after birth for all infants)
- maternal side effects(during labour and within 24hours after birth)
研究者
Rania Hassan Mostafa
Principal Investigator
Ain Shams Maternity Hospital