The Effect of Crowning Time on Levator Ani Muscle Avulsion

NCT07210788 | Recruiting

• 1 other identifier: 2024-5391
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Levator ani muscle is one of the main components of perineal muscles and plays a crucial role in urinary continence and pelvic organ support. An avulsion, detachment from its insertion, of this muscle can occur during vaginal birth. It is well known that this major injury can cause many symptoms such as urinary incontinence and pelvic organ prolapses. Some risk factors of this important injury have been identified in the literature, such as the use of forceps. However, to date, no study has evaluated the impact of the crowning of the fetal head during labor on perineal muscles, specifically the levator ani muscle avulsion. Hence, the objectives of this study are to evaluate the association i) the time of the crowning of the fetal head during labor and levator ani muscle avulsion, ii) the time of the crowning of the fetal head and urogynecological symptoms, and iii) use of episiotomy and levator ani muscle avulsion. Postpartum primiparous women will undergo a 4D transperineal ultrasound to evaluate their pelvic muscles and complete questionnaires assessing urogynecological symptoms.

Conditions

Time of the Crowning of the Fetal Head; Levator Ani Avulsion; Labor Delivery; Postpartum

Keywords

levator ani; levator ani avulsion; crowning time; crowning time of the fetal head; primiparous; singleton foetus; vertex position; postpartum

Outcome Measures

Primary Outcomes (2)

• Number of participants with complete and partial unilateral or bilateral avulsion of the levator ani muscles in the post-partum period

  Diagnostic established with standard levator-urethra gap measures assessed with a transperineal 4D ultrasound

  In the post-partum period, up to 1 year post-partum

• Crowning time of the fetal head

  The time between the crowning of the fetal head and birth is systematically recorded during labor at the study center for all deliveries. Only participants who meet the inclusion criteria are considered for the study.

  The data was obtained from the medical records of each participant during labor.

Secondary Outcomes (3)

• Rate and type of perineal tears

  The data was obtained from the medical records of each participant during labor.

• Incidence and severity of urogynecological symptoms

  In the post-partum period, up to 1 year post-partum

• Use of episiotomy

  The data was obtained from the medical records of each participant during labor.

Study Arms (1)

Primiparous women with singleton vertex position having a spontaneous vaginal birth

This cohort study follows primiparous women having had an unassisted by forceps or vacuum labor in post-partum with a 4D ultrasound of the perineum.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population will recruit primiparous postpartum women who meet the inclusion criteria and gave birth at CHUS Fleurimont during the recruitment period.

You may qualify if:

• Primiparous women GxT1 At term: ≥ 37+0 weeks of gestation (included) Spontaneous vaginal delivery (SVD) Cephalic presentation History of miscarriage before 20 weeks or with a fetal weight \< 350g

You may not qualify if:

• Contraindications to vaginal delivery Assisted vaginal delivery Age under 18 years Shoulder dystocia Extensive pelvic reconstructive surgery (e.g., bladder exstrophy repair) Term intrauterine fetal demise Twin or multifetal pregnancy

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator

Study Sites (1)

CHUS Fleurimont

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

Study Officials

• Mélanie Morin, PT

  Université de Sherbrooke

  STUDY DIRECTOR

Central Study Contacts

Megan Boutilier, resident in OBGYN, Medical Degree

CONTACT

819-346-1110; megan.boutilier@usherbrooke.ca

Marie-Élisabeth Bouchard, MD, Urogynecologist

CONTACT

819-346-1110; marie-elisabeth.bouchard@usherbrooke.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: October 7, 2025
• Study Start: April 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)