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

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

Detailed Description
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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.

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

Conditions
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Labor Complication, Avulsion

Intervention / Treatment
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* Procedure: Fundal Pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case (Kristaller Group)<br>Group of kristeller maneuver applied in the second stage of labor due to clinical necessity. | Procedure: Fundal Pressure<br>* Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor<br>|
| Control (no Kristaller Group)<br>The control group not required to kristeller maneuver | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun