Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- the percentage of patients with chorioamnionitis
研究概览
简要总结
Prelabour rupture of membrane is defined as rupture of membranes prior to the onset of labour. Approximately 8% of pregnant women at term experience PROM, but the decision as to how term PROM should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. Although for the majority of women labour will start spontaneously within 24 hours following term PROM, up to 4%of women will not experience spontaneous onset of labour within seven days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preterm premature rupture of membranes.
- •Singleton gestation.
- •Pregnant between 34 weeks 0 days to 36 weeks 6 days.
排除标准
- •Non cephalic presentation.
- •fetal distress.
- •Labour on admission.
- •Medical or obstetric complications such as(suspected chorioamnionitis ,hypertensive disorders, diabetes mellitus , active genital herpes , placenta previa , infection, meconium stained amniotic fluid ,severe fetal anomalies).
研究组 & 干预措施
conservative group
patient assigned to the observation group will be assessed in the labor and delivery suite for 2 to 4 hours with continuous external fetal heart rate monitoring and tocodynamometry. In the absence of non reassuring fetal status , initiation of labor , or infection , these women will be transferred to antepartum room where maternal vital signs. Patients will be restricted to bed rest with bathroom privileges and remained hospitalized until delivary .
干预措施: follow up (Procedure)
active group
Patients assigned to active management will receive induction of labour with intravenous oxytocin with use of controlled infusion pump Oxytocin will be administered by continuous intravenous infusion beginning at 0.5 mU/min , doubling the dose every 30 minutes to 2mU/min , and then increasing by 2 mU/min every 30 minutes there after until a satisfactory labor pattern is achieved.
干预措施: induction of labor (Procedure)
结局指标
主要结局
the percentage of patients with chorioamnionitis
时间窗: 24 hours
Clinical chorioamnionitis is defined in the absence of other causes of hyperpyrexia by a temprature of \>38 C with either uterine tenderness , leucocytosis , maternal or fetal tachycardia , or foul smelling vaginal discharge
次要结局
未报告次要终点
研究者
Asmaa Abd El Sattar Ahmed
Principal investigator
Assiut University