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

NCT ID: NCT03752879

Last Updated: 2020-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-18

Study Completion Date

2019-10-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Labor Complication Avulsion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case (Kristaller Group)

Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.

Fundal Pressure

Intervention Type PROCEDURE

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

No interventions assigned to this group

Interventions

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Fundal Pressure

Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakıf University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 32902763 (View on PubMed)

Other Identifiers

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BezmialemVU Fundal Pressure

Identifier Type: -

Identifier Source: org_study_id

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