Time of the Crowning of the Fetal HeadNCT07210788
The Effect of Crowning Time on Levator Ani Muscle Avulsion
An observational study of Time of the Crowning of the Fetal Head and Levator Ani Avulsion, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Time of the Crowning of the Fetal Head, Levator Ani Avulsion, Labor Delivery
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2024to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megan Boutilier, resident in OBGYN, Medical Degree contact
Marie-Élisabeth Bouchard, MD, Urogynecologist contact
Canada1 site, 1 recruiting
- Recruiting
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5H3
Megan Boutilier, resident in OBGYN, Medical Degree, 819-346-1110 ext. 72391, megan.boutilier@usherbrooke.ca
Marie-Élisabeth Bouchard, MD, Urogynecologist, 819-346-1110 ext. 72574, marie-elisabeth.bouchard@usherbrooke.ca
About this study
Official title: Evaluation of Crowning Time on the Incidence of Levator Ani Muscle Avulsion
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.
Read the detailed description
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.
- Keywords
- levator ani, levator ani avulsion, crowning time, crowning time of the fetal head, primiparous, singleton foetus, vertex position, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: The data was obtained from the medical records of each participant during labor.
Secondary outcomes (3)
Rate and type of perineal tears
Grade of perineal tear collected in the medical file
Measured: The data was obtained from the medical records of each participant during labor.
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:
- UDI (Urinary Distress Inventory): range 0-300
- POPDI (Pelvic Organ Prolapse Distress Inventory): range 0-300
- 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
Measured: In the post-partum period, up to 1 year post-partum
Use of episiotomy
Type and use of episiotomy collected in the medical file
Measured: The data was obtained from the medical records of each participant during labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start23 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time of the Crowning of the Fetal HeadStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
- Investigators
- Mélanie Morin, PT, Study director, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210788
- Sponsor's protocol ID
- 2024-5391
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available upon approval by the principal investigator and study team.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Crowning Time on the Incidence of Levator Ani Muscle Avulsion
- ClinicalTrials.gov ID
- NCT07210788
- Acronym / sponsor ID
- 2024-5391
- Keywords
- levator ani, levator ani avulsion, crowning time, crowning time of the fetal head, primiparous, singleton foetus, vertex position, postpartum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Diagnostic established with standard levator-urethra gap measures assessed with a transperineal 4D ultrasound
Crowning time of the fetal head
Time frame: The data was obtained from the medical records of each participant during labor.
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.
3 secondary outcomes
Rate and type of perineal tears
Time frame: The data was obtained from the medical records of each participant during labor.
Incidence and severity of urogynecological symptoms
Time frame: In the post-partum period, up to 1 year post-partum
Use of episiotomy
Time frame: The data was obtained from the medical records of each participant during labor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available upon approval by the principal investigator and study team.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Boutilier, resident in OBGYN, Medical Degree contact
Marie-Élisabeth Bouchard, MD, Urogynecologist contact
Mélanie Morin, PT study director
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Time of the Crowning of the Fetal Head and Levator Ani Avulsion, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Boutilier, resident in OBGYN, Medical Degree (819-346-1110 ext. 72391, megan.boutilier@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.