Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of cases with perinatal complications
研究概览
简要总结
Induction of labor is one of the most common interventions in obstetrics. In the past decade, the rates of labor induction at term have doubled from approximately 9% to 23% in the United States and from 10% to 20.4% in China. The majority of women undergoing labor induction requires cervical ripening for the unfavorable cervixes. As globally, it is still required to explore an optimal induction method. Foley catheter was among the oldest mechanical approaches, while prostaglandin E2 vaginal suppository (PGE2) one of the most popular pharmacological agents for cervical ripening. There were studies reporting similar cesarean section rates between these two methods. However, there are no randomized control trials (RCTs) with adequate power to compare their frequencies of severe perinatal complications. The investigators aim to compare the effectiveness and safety of Foley catheter versus PGE2 for induction of labor among term pregnant women with an unfavourable cervix.
详细描述
The investigators propose a single center, open-label, randomized controlled clinical trial (1:1 treatment ratio) in Guangzhou Women and Children's Medical Center. Women with a term pregnancy, an indication for induction of labor, and a live singleton fetus at cephalic presentation, intact membranes, an unfavorable cervix, no prior cesarean section or contraindication to vaginal delivery, are eligible to participate. After informed consent, they will be randomized to undergo induction of labor by Foley catheter or PGE2.
Our primary outcomes will be (I) a composite of severe perinatal complications and (II) vaginal delivery. Before the formal recruitment of this RCT, a pilot study with a sample size of 200 pregnant women will be performed.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women scheduled for induction of labor.
- •Women aged ≥ 18 years old
- •≥ 37 weeks of gestation
- •Live singleton pregnancy in cephalic presentation
- •Intact membranes
- •Cervical Bishop score < 6
- •Informed consent.
排除标准
- •Contraindications for vaginal delivery.
- •Prior cesarean section
- •Known hypersensitivity for Foley catheter or PGE2
- •Non-reassuring fetal status
- •Lethal fetal congenital anomaly
研究组 & 干预措施
Induction of labor with Foley catheter
A Foley catheter will be introduced transcervically in women allocated in this group.
干预措施: Induction of labor with Foley catheter (Device)
Induction of labor with PGE2
PGE2 (1mg) will be inserted into the posterior vaginal fornix.
干预措施: Induction of labor with PGE2 (Drug)
结局指标
主要结局
Number of cases with perinatal complications
时间窗: Up to 3 weeks
This primary outcome will be a composite of cases with severe perinatal complications and consists of one or more of the following: need for respiratory support within hours after birth, Apgar score \< 7 at 1 minutes, Apgar score \<7 at 5 minutes, umbilical cord arterial potential of hydrogen (pH ) \< 7.10, birth trauma (including bone fracture, neurologic injury, or retinal hemorrhage), hypoxic-ischemic encephalopathy or need for therapeutic hypothermia, seizure, pneumonia, meconium aspiration syndrome, neonatal meningitis, neonatal sepsis, infant respiratory distress syndrome, pneumothorax or pneumomediastinum, apnoea, necrotising enterocolitis, clinical diagnosis of asphyxia, intraventricular haemorrhage, perinatal death (fetal or neonatal death occurring during childbirth, or up to 7 completed days after birth) or admission to the neonatal intensive care unit (NICU) for \>48 hours. Each component of this outcome is described from outcome 3 to outcome 21.
Percentage of vaginal delivery
时间窗: Up to 1 week
The co-primary outcome is vaginal delivery.
次要结局
- Number of neonates with Apgar score < 7 at 5 minutes(On the day of delivery)
- Number of neonates need for respiratory support(Up to 1 week)
- Number of neonates with Apgar score < 7 at 1 minutes(On the day of delivery)
- Number of neonates with pneumonia(Up to 2 weeks)
- Number of neonates with umbilical cord arterial pH < 7.10(On the day of delivery)
- Number of neonates with infant pneumothorax or pneumomediastinum(Up to 2 weeks)
- Number of neonates with birth trauma(Up to 1 week)
- Number of neonates with hypoxic-ischemic encephalopathy or need for therapeutic hypothermia(Up to 1 week)
- Number of neonates with seizure(Up to 2 weeks)
- Number of neonates with meconium aspiration syndrome(Up to 2 week)
- Number of neonates with neonatal meningitis(Up to 4 weeks)
- Number of neonates with neonatal sepsis(Up to 2 weeks)
- Number of neonates with apnoea(Up to 2 weeks)
- Number of neonates with necrotising enterocolitis(Up to 2 weeks)
- Number of neonates with infant respiratory distress syndrome(Up to 2 weeks)
- Number of neonates with clinical diagnosis of asphyxia(Up to 2 weeks)
- Number of perinatal deaths(up to 2 weeks)
- Number of neonates with intraventricular hemorrhage(Up to 2 week)
- Number of neonates admission to the NICU for >48 hours(up to 2 weeks)
- Number of cases with maternal secondary outcomes(Up to 2 weeks)
- Number of mothers with cardio-respiratory arrest(Up to 2 weeks)
- Number of mothers with damage to internal organs(Up to 2 weeks)
- Number of mothers with postpartum hemorrhage(Up to 1 week)
- Number of mothers have hysterectomy(Up to 2 weeks)
- Number of mothers have intensive care admission(Up to 3 weeks)
- Number of mothers have uterine rupture(Up to 2 weeks)
- Number of maternal infection(Up to 2 weeks)
- Number of mothers have pulmonary embolism(Up to 2 weeks)
- Number of mothers have stroke(Up to 2 weeks)
- Scores of maternal satisfaction with the intervention of labor induction(Up to 2 weeks)
- Number of maternal death(Up to 2 weeks)
- Number of neonates with hyperbilirubinemia(Up to 2 weeks)
- Number of neonates with hypoglycemia(Up to 2 weeks)
- Length of neonatal admission (days)(Up to 3 weeks)
- Number of neonates with cephalohematoma(Up to 2 weeks)
- Number of neonates have shoulder dystocia(Up to 1 week)
- Number of neonates have admission to the NICU < 48 hours(Up to 1 week)
- Number of cases with indication of caesarean section(Up to 1 week)
- Number of cases with indication of instrumental delivery(Up to 1 week)
研究者
Zehong Zhou
Principle investigator
Guangzhou Women and Children's Medical Center