- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03752879
The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery
The Association Between Fundal Pressure in Second Stage of Labor (Kristeller Maneuver) and and Pelvic Floor Trauma After Vaginal Delivery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34093
- Bezmialem Vakıf University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Case (Kristaller Group)
Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
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Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
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Control (no Kristaller Group)
The control group not required to kristeller maneuver
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
24 hour
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BezmialemVU Fundal Pressure
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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