A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Any perineal laceration (first through fourth degree)
研究概览
简要总结
The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.
详细描述
This is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. It will include nulliparous women presenting in active labor to the L&D East (low risk) Unit at Parkland Hospital, > 370/7 weeks gestation, with singleton fetuses in cephalic presentation. The primary outcome variable is any perineal laceration. Secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women presenting in active labor to Parkland L&D East Unit
- •≥ 370/7 weeks gestation
- •Singleton fetus in cephalic presentation
- •≥ 4 cm but ≤ 8 cm of cervical dilation
- •No medical or obstetrical complication
排除标准
- •Women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction
- •Prior history of perineal trauma requiring surgical repair or known congenital perineal malformation
- •Non-English or non-Spanish speaking
研究组 & 干预措施
Stirrups delivery
Mom will be assigned to deliver with legs positioned in stirrups
干预措施: Stirrups delivery vs bed delivery (Other)
Bed delivery
Mom will be assigned to deliver with the legs positioned in bed in the supine position
干预措施: Stirrups delivery vs bed delivery (Other)
结局指标
主要结局
Any perineal laceration (first through fourth degree)
时间窗: Immediately post delivery
次要结局
- Third and fourth-degree perineal lacerations(Immediately post delivery)
研究者
Marlene Corton
Associate Professor
University of Texas Southwestern Medical Center