Recruiting

Observational Study

Sponsor:

Université de Sherbrooke

Code:

NCT07210788

Conditions

Time of the Crowning of the Fetal Head

Levator Ani Avulsion

Labor Delivery

Postpartum

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07210788

Start date

Apr 23, 2024

Status verified date

Aug, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

92 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of participants with complete and partial unilateral or bilateral avulsion of the levator ani muscles in the post-partum period [ Time Frame: In the post-partum period, up to 1 year post-partum ]
  • Crowning time of the fetal head [ Time Frame: The data was obtained from the medical records of each participant during labor. ]

Central Contacts and Locations

Central contacts

Megan Boutilier, resident in OBGYN, Medical Degree

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

Marie-Élisabeth Bouchard, MD, Urogynecologist

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

Locations

CHUS Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H3

Contacts

Megan Boutilier, resident in OBGYN, Medical Degree

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

Marie-Élisabeth Bouchard, MD, Urogynecologist

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

Principal Investigator:

Mélanie Morin, PT, PT

More Information

Sponsor

Université de Sherbrooke

Last update posted

Oct 7, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-10-07.