The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery
Sponsor study identifier
observational
86
1 country
1
Study Start
May 18, 2019
Actual (reported)Primary Completion
July 18, 2019
Actual (reported)Study Completion
October 18, 2019
Actual (reported)We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 18, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 20, 2018
Actual (reported)November 26, 2018
Actual (reported)May 18, 2019
Actual (reported)July 18, 2019
Actual (reported)October 18, 2019
Actual (reported)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
Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
The control group not required to kristeller maneuver
Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.
Bezmialem Vakıf University Hospital
Istanbul, 34093, Turkey (Türkiye)
Takmaz T, Aydin S, Gorchiyeva I, Karasu AFG. The usual suspect: cross-sectional study of fundal pressure at second stage of delivery and the association with pelvic floor damage. Int Urogynecol J. 2021 Jul;32(7):1917-1924. doi: 10.1007/s00192-020-04523-x. Epub 2020 Sep 9.
86 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2018
First Posted
November 26, 2018
Study Start
May 18, 2019
Actual (reported)Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
Contact the study team to confirm eligibility.
Primary Completion
July 18, 2019
Actual (reported)Study Completion
October 18, 2019
Actual (reported)Last Updated
May 28, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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