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Completed

NCT Number: NCT03752879

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

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

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Key information

Conditions

Labor Complication Avulsion Female Urogenital Diseases and Pregnancy Complications Fractures, Avulsion Fractures, Bone Obstetric Labor Complications Pregnancy Complications Urogenital Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bezmialem Vakıf University Hospital

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fundal Pressure

Procedure

Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor

Primary outcomes

  1. levator ani muscle (LAM) injury

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2018
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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