A Randomized Controlled Trial of Transcervical Foley Balloon Compared to Controlled Release Prostaglandin (Cervidil) for Labor Induction and Cervical Ripening in Term and Near Term Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Time Of Start Of Induction Of Labor To Delivery
研究概览
简要总结
OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction.
HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).
详细描述
BACKGROUND:
Induction of labor is performed in 25% of all women who present for delivery at the Banner Good Samaritan Medical Center (1). The commonality of labor induction is not only a local issue. The national cesarean rate has risen to 31.1%, which represents a 50% increase since 1996 (2). Part of the reason for this increase in the cesarean delivery rate is the pervasive use of labor induction. This risk can be mitigated with the use of cervical ripening agents when a cervix is unfavorable for induction. Both pharmacological (prostaglandin analogues) ripening agents and mechanical methods are utilized, but no single method has been shown to offer a significant advantage over the other methods. Many centers, including ours, have several different methods available, since each ripening method may have one or more unique contraindications for their use during labor induction.
One emerging modality for cervical ripening and labor induction has been transcervical Foley balloon catheter placement, which is thought to operate by mechanical dilation of the cervix. The modality has become popular in part due to its efficacy, safety and low cost. The most popular method of labor induction at Banner Good Samaritan Medical Center is a controlled release prostaglandin application (Cervidil™). This modality is expensive and may require more than one dose, thus increasing duration of labor induction and hospital costs. A thorough literature search was performed on PubMed with the search terms "foley" "labor induction" "prostaglandin E2 vaginal insert" from 1972 to 2009 and to date there have been no randomized trials comparing the efficacy of these two modalities for labor induction. Additionally, the clinical trials.gov site (www.clinicaltrials.gov) was searched and there are no active or previously complete studies of Cervidil™ compared to transcervical Foley balloon for labor induction. Therefore, we propose a randomized controlled clinical trial to evaluate the comparative efficacies of these two modalities for cervical ripening and labor induction in term and near term women.
METHODOLOGY:
All HIPAA and GCP regulations will be followed and IRB approval will be obtained.
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
- 是
入选标准
- •Cervix < 3 cm dilated. If 2cm dilated, must be < 80% effaced.
- •Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
- •Singleton gestation
- •Cephalic presentation
排除标准
- •Regular uterine contractions (more frequent than every 5 minutes)
- •Prior transverse uterine incision or any obstetric contraindication to labor
- •Fever (defined as a temperature of 38°C or higher)
- •Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
- •Fetal death
- •Placenta previa
- •Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
- •Non-reassuring fetal heart rate pattern
研究组 & 干预措施
FOLEY BALLOON
Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery
干预措施: FOLEY BALLOON (Device)
CERVIDIL
干预措施: CERVIDIL (Dinoprostone) (Drug)
结局指标
主要结局
Time Of Start Of Induction Of Labor To Delivery
时间窗: Hours
The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction. There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours. Key word: INDUCTION OF LABOR
次要结局
未报告次要终点