Comparison of Pre-Induction Cervical Ripening Using Prepidil Gel Administered Through a Urinary Balloon Catheter.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Vaginal Delivery
研究概览
简要总结
This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
详细描述
Title: Comparison of pre-induction cervical ripening using Prepidil gel administered through a urinary balloon catheter
Precis- This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
Background
Induction of labor is a common intervention during pregnancy1. The frequency of hospital admissions for induction of labor is increasing in the United States. Indications for induction of labor include maternal disease, fetal complications and social/geographical issues. Obstetricians may also choose elective induction, to facilitate delivery at term for the physician or patient who does not have a medical indication for delivery.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising2. This has led to a renewed effort to examine the effectiveness of the varied methods of induction3-5.
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
- 否
入选标准
- •Single, live fetus
- •Cephalic (head-first) presentation
- •Reassuring fetal health assessment
- •Gestational age between 26 and 42 weeks
- •Maternal age 18 and above
- •Bishop score less than 5
排除标准
- •Multiple Gestation (twins, triplets, quadruplets)
- •Fetal demise
- •Fetal malpresentation
- •Estimated fetal weight less than 500 grams or more than 4000 grams
- •Placenta previa
- •Non-reassuring fetal health assessment
- •Maternal asthma
- •Latex allergy
- •Spontaneous labor
- •Other contraindication to vaginal delivery
研究组 & 干预措施
Urinary Balloon Catheter Only
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
干预措施: Urinary Balloon Catheter (Device)
Prepadil Only
Prepidil Only : Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
干预措施: Prepidil Gel (Drug)
Combined Urinary Catheter & Prepidil Gel
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
干预措施: Combined Urinary Catheter & Prepidil Gel (Other)
结局指标
主要结局
Vaginal Delivery
时间窗: Gestational age 26-42 weeks
The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.
次要结局
未报告次要终点