The Effect of Crowning Time on Levator Ani Muscle Avulsion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversité de Sherbrooke
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The target population will recruit primiparous postpartum women who meet the inclusion criteria and gave birth at CHUS Fleurimont during the recruitment period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
92 Participants
are grouped into 1 trial groupGroup A: Primiparous women with singleton vertex position having a spontaneous vaginal birth
Trial outcomes
Primary outcomes
1
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
Time frame
In the post-partum period, up to 1 year post-partum2
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.
Time frame
The data was obtained from the medical records of each participant during labor.Secondary outcomes
1
Rate and type of perineal tears
Grade of perineal tear collected in the medical file
Time frame
The data was obtained from the medical records of each participant during labor.2
Incidence and severity of urogynecological symptoms
Validated questionnaires on urogynecological symptoms: PFDI-46 and ICIQ-IU-SF PFDI-46 (Pelvic Floor Distress Inventory - 46 Items) Full title: Pelvic Floor Distress Inventory Structure \& Scoring: It comprises three subscales: 1. UDI (Urinary Distress Inventory): range 0-300 2. POPDI (Pelvic Organ Prolapse Distress Inventory): range 0-300 3. CRADI (Colorectal-Anal Distress Inventory): range 0-400 Interpretation: Higher scores indicate worse symptom distress-i.e., a higher burden of pelvic floor symptom ICIQ-UI-SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) Full title: International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form Scoring: Total score: 0-21 (sum of items 3, 4, and 5; items 1, 2 are demographic, one item is unscored) Interpretation: A higher score indicates greater severity of urinary incontinence and a greater negative impact on quality of life
Time frame
In the post-partum period, up to 1 year post-partum3
Use of episiotomy
Type and use of episiotomy collected in the medical file
Time frame
The data was obtained from the medical records of each participant during labor.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Université de Sherbrooke
Lead sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborator
Source ClinicalTrials.gov