Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Reduction in the length of the second stage of labor
研究概览
简要总结
Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.
The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract. Neonatal and maternal morbidities will be also assessed.
The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either:
- Group 1 who will receive the standard care during labor and delivery
- Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel The goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40 years
- •Intended vaginal delivery
- •Singleton baby in vertex presentation
- •Low risk pregnancy at term (37-42 weeks of gestation)
- •Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
- •Signed written informed consent
排除标准
- •Contraindications for vaginal delivery (placenta previa, active herpes infection, etc...)
- •Advanced cervical dilation (≥ 5 cm)
- •Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
- •Non reassuring fetal heart tracing
- •Prolonged rupture of the membranes (24 hours)
- •Suspected major fetal malformations
- •Suspected cephalopelvic disproportion
研究组 & 干预措施
Group 2
Group 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous [never delivered beyond 20 weeks of gestation in a previous pregnancy] or primiparous or more)
干预措施: Natalis (Drug)
结局指标
主要结局
Reduction in the length of the second stage of labor
时间窗: Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes
40% reduction in the duration of the second stage of labor with a calculated average duration of 66.5 min. Thus a reduction to 39.9 minutes for every patient recruited
次要结局
未报告次要终点
研究者
Elie Hobeika
Assistant Professor of Clinical Obstetrics and Gynecology
American University of Beirut Medical Center