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临床试验/NCT03752879
NCT03752879已完成不适用

The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
levator ani muscle (LAM) injury

研究概览

简要总结

We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.

详细描述

We will recruit women immediately following their first vaginal delivery. Women who underwent Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure) will be recruit matched by BMI, second stage duration and birthweight. All women will be invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases and controls.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • First delivery
  • Term pregnancy (37-41w)

排除标准

  • Instrumental vaginal delivery
  • Multifetal pregnancy
  • Previous vaginal or cesarean delivery
  • Refused consent and uncooperative patient for effective Valsalva maneuver
  • Handicap in lithotomy position
  • Women without regular and active contractions
  • Epidural analgesia

结局指标

主要结局

levator ani muscle (LAM) injury

时间窗: 24 hour

The aim of the study is to investigate levator ani muscle (LAM) injury, loss of tenting, biometric measurements of LAM and genital hiatus after vaginal delivery and investigate the association between fundal pressure in the second stage of labor (Kristeller maneuver). All recruited women will be invited to undergo a transperineal 3D ultrasound (TPUS) scan at 24 hours after delivery. we will acquire two 3D volumes for each patient: one under maximum pelvic floor muscle contraction (PFMC) and the other under maximum Valsalva's maneuver. Ballooning" will diagnosed with a pelvic hiatal area of more than 25 cm2 during maximum Valsalva. A complete avulsion of the puborectalis muscle will diagnose if an abnormal insertion of the muscle will be detected on all three central slices. We will use a levator-urethral gap more than 2.5 cm to define an abnormal insertion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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