NCT Number: NCT07210788
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Sherbrooke, Quebec, J1H 5H3, Canada
Location status: Recruiting
Marie-Élisabeth Bouchard, MD, Urogynecologist
CONTACT
819-346-1110 ext. 72574
Megan Boutilier, resident in OBGYN, Medical Degree
CONTACT
819-346-1110 ext. 72391
Mélanie Morin, PT, PT
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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
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.
Time frame: The data was obtained from the medical records of each participant during labor.
Grade of perineal tear collected in the medical file
Time frame: In the post-partum period, up to 1 year post-partum
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:
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: The data was obtained from the medical records of each participant during labor.
Type and use of episiotomy collected in the medical file
Contact information is provided by the study sponsor or research team.
Marie-Élisabeth Bouchard, MD, Urogynecologist
CONTACT
819-346-1110 ext. 72574
Megan Boutilier, resident in OBGYN, Medical Degree
CONTACT
819-346-1110 ext. 72391
Université de Sherbrooke
Other
Evaluation of Crowning Time on the Incidence of Levator Ani Muscle Avulsion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07140211
Cardiovascular Diseases, Embolism and Thrombosis
Baden, Switzerland
View Trial DetailsNCT06557005
Anxiety, Anxiety Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT06284278
Musculoskeletal Pain, Neurologic Manifestations
Tainan, Taiwan
View Trial DetailsNCT07419399
Postpartum, Rectus Muscle Diastasis
Valencia, Spain
View Trial Details