An observational study in Labor Complication and Avulsion, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-28.
Sponsored by Bezmialem Vakif University · Observational
We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.
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.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's enrollment of 86 is below the median of 300 across 25 observational studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.
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Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.
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Exclusion Criteria:
Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
Procedure: Fundal Pressure
The control group not required to kristeller maneuver
Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
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.
Time frame: 24 hour
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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