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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752879
Recruitment Status : Completed
First Posted : November 26, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

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

Condition or disease Intervention/treatment
Labor Complication Avulsion Procedure: Fundal Pressure

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   biological female gender
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Over 18 years old ,term primiparous women with singleton pregnancies and vaginal delivery.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Turkey
Bezmialem Vakıf University Hospital
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03752879    
Other Study ID Numbers: BezmialemVU Fundal Pressure
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bezmialem Vakif University:
Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun
Additional relevant MeSH terms:
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Obstetric Labor Complications
Fractures, Avulsion
Fractures, Bone
Wounds and Injuries
Pregnancy Complications