The Effect of Crowning Time on Levator Ani Muscle Avulsion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-23

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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This is a prospective cohort study evaluating the impact of the crowning time of the fetal head in the second stage of labor on the incidence of levator ani muscle avulsion. Levator ani muscle is hypothesized to avulse during the distension of the pelvic floor muscles, as during a forceps use, and most probably during the crowning of the fetal head. In the study center, the crowning of the fetal head is systematically calculated during labor by nurses and doctors. To eliminate some potential confounding factors, only primiparous women with spontaneous vaginal delivery of a vertex position baby will be recruited in the post-partum period. In order to evaluate the presence of levator ani muscle avulsion, they will be assessed with a 4D transperineal ultrasound by using a standard diagnosis protocol. The delivery hospital file will then be examined to collect potential confounding variables. Prior to data collection, all study participants will give their written informed consent. This study will add more literature to the prevention of the levator ani muscle avulsion and its long-term complications.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes