Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC):a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- length of the second stage of labor
研究概览
简要总结
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 in women undergoing a Vaginal Birth After Cesarean (VBAC).
详细描述
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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Women who have had only one prior cesarean birth with no previous vaginal delivery, are eligible for VBAC and plan to attempt a VBAC after counseling.
- •Singleton baby in vertex presentation
- •Low-risk pregnancy at term (37-41 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...)
- •Suspected amniotic infection (fever, foul-smelling discharge, fetal tachycardia, abdominal pain)
- •A 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
obstetric gel group
they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.
干预措施: obsteric gel(k-Y jelly) (Drug)
结局指标
主要结局
length of the second stage of labor
时间窗: 1 hour
the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.
次要结局
未报告次要终点
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University