The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery
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|ClinicalTrials.gov Identifier: NCT03752879|
Recruitment Status : Completed
First Posted : November 26, 2018
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment|
|Labor Complication Avulsion||Procedure: Fundal Pressure|
|Study Type :||Observational|
|Actual Enrollment :||86 participants|
|Official Title:||The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery|
|Actual Study Start Date :||May 18, 2019|
|Actual Primary Completion Date :||July 18, 2019|
|Actual Study Completion Date :||October 18, 2019|
Case (Kristaller Group)
Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
Procedure: Fundal Pressure
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752879
|Bezmialem Vakıf University Hospital|
|Istanbul, Turkey, 34093|