The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery

Completed

• Conditions: Labor Complication; Avulsion
• Interventions: Procedure: Fundal Pressure

• Registration Number: NCT03752879
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-26
• Study Start: 2019-05-18
• Primary Completion: 2019-07-18
• Study Completion: 2019-10-18
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case (Kristaller Group)	Fundal Pressure	Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.

Primary Outcome Measures

Name	Time	Method
levator ani muscle (LAM) injury	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.

Trial Locations

Locations (1)

Bezmialem Vakıf University Hospital; 🇹🇷 Istanbul, Turkey