Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Maternal infectious morbidity
研究概览
简要总结
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).
详细描述
Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.
PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.
In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
- •Women at gestational age 370/7 or more.
- •Vertex presentation.
排除标准
- •Age 18 and under.
- •High order gestation.
- •Women with contraindication for a vaginal delivery.
- •Active labor.
- •Documented fetal anomalies.
- •Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
- •Non reassuring fetal heart rate tracing.
- •Positive group B streptococcus status.
研究组 & 干预措施
Immediate oxytocin infusion
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.
干预措施: Oxytocin (Drug)
Expectant management for 24 hours
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Maternal infectious morbidity
时间窗: Up to 48 hours postpartum
Maternal chorioamnionitis and/ or endometritis
次要结局
- Adverse maternal outcome(Up to 48 hours postpartum)
- Length of latent and active phases of labor.(During Labor)
- Adverse neonatal outcome(Up to 48 hours postpartum)