Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT07210788

The Effect of Crowning Time on Levator Ani Muscle Avulsion

Led by Université de Sherbrooke · Updated on 2025-10-07

92

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

U

Université de Sherbrooke

Lead Sponsor

C

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The Effect of Crowning Time on Levator Ani Muscle Avulsion

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Primiparous women (first pregnancy) at term (37 weeks or more)
  • Spontaneous vaginal delivery planned
  • Cephalic (head-down) presentation of the baby
  • History may include miscarriage before 20 weeks or fetal weight under 350g
Not Eligible

You will not qualify if you...

  • Contraindications to vaginal delivery
  • Assisted vaginal delivery (forceps or vacuum)
  • Age under 18 years
  • Shoulder dystocia during delivery
  • Extensive pelvic reconstructive surgery (e.g., bladder exstrophy repair)
  • Fetal death at term
  • Twin or multiple pregnancies

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHUS Fleurimont

Sherbrooke, Quebec, Canada, J1H 5H3

Actively Recruiting

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Research Team

M

Megan Boutilier, resident in OBGYN, Medical Degree

CONTACT

M

Marie-Élisabeth Bouchard, MD, Urogynecologist

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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The Effect of Crowning Time on Levator Ani Muscle Avulsion | DecenTrialz