Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.
详细描述
This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.
The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton Pregnancy
- •37.0 and 41.0 gestational age
- •Confirmed Rupture of Membranes
- •Group B Streptococcus Negative
- •Cephalic Presentation
- •Absence of contractions for at least 60 minutes following rupture
- •Absence of contractions at time of enrolment
排除标准
- •Contraindication to Vaginal Delivery
- •Previous Uterine Surgery, including Caesarean Section
- •Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery
- •Documented history of cervical incompetence
- •High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer.
- •Immunosuppressed State
- •Active Vaginal Infection
研究组 & 干预措施
Oxytocin
Induction of Labour with Oxytocin Alone
干预措施: Oxytocin (Drug)
Intracervical Catheter
Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
干预措施: Intracervical Balloon Catheter (Procedure)
Intracervical Catheter
Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Feasibility
时间窗: 48 hours
次要结局
- Intrapartum Fever(48 Hours)
- Duration of Labour(48 hours)
- NICU Admission(0-7 days postpartum)
- Chorioamnionitis(48 Hours)
- Patient Satisfaction(0-6 weeks Postpartum)