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

May 27, 2020 updated by: Bezmialem Vakif University

The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and 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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34093
        • Bezmialem Vakıf University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case (Kristaller Group)
Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
Control (no Kristaller Group)
The control group not required to kristeller maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2019

Primary Completion (Actual)

July 18, 2019

Study Completion (Actual)

October 18, 2019

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor Complication

Clinical Trials on Fundal Pressure

3
Subscribe