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

Labor Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752879
• Other study ID #: BezmialemVU Fundal Pressure
• Status: Completed
• Start date: May 18, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: May 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avulsion
• Labor Complication
• Obstetric Labor Complications

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levator ani muscle (LAM) injury	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