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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03752879

Enrollment

Registered

2018-11-26

Start date

2019-05-18

Completion date

2019-10-18

Last updated

2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avulsion, Labor Complication

Keywords

Kristeller maneuver,LAM avulsion,3D transperineal ultrasoun

Brief summary

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

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.

Interventions

PROCEDUREFundal Pressure

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
levator ani muscle (LAM) injury	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026