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

B

Bezmialem Vakif University

Status

Completed

Conditions

Avulsion
Labor Complication

Treatments

Procedure: Fundal Pressure

Study type

Observational

Funder types

Other

Identifiers

NCT03752879
BezmialemVU Fundal Pressure

Details and patient eligibility

About

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

Full 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.

Enrollment

86 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Case (Kristaller Group)
Description:
Group of kristeller maneuver applied in the second stage of labor due to clinical necessity.
Treatment:
Procedure: Fundal Pressure
Control (no Kristaller Group)
Description:
The control group not required to kristeller maneuver

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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