Clinical trial NCT04980235: Evaluation of Levator Ani Muscle Injury in Primiparous
Official title: Evaluation of Levator Ani Muscle Injury in Primiparous Women at One and Six Weeks Postpartum Using 4D Transperineal Ultrasound: Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Disorders
Keywords: levator hiatus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 355
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was performed at Shatby maternity university hospital in Alexandria where 12000 deliveries per year are achieved . Over a 4-months period (February-June 2021.

355 eligible Egyptian women

Brief summary: pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur . Transperineal ultrasonography study pelvic floor pathology with minimal discomfort to the patient and lower cost than magnetic resonance imaging.

Detailed description: 355 eligible Egyptian women had been enrolled Maternal Medical, surgical and obstetrical history was obtained. Demographic data (maternal age, maternal body mass index, duration of second stage labor, episiotomy, maternal injuries, neonatal birth weight, and neonatal head circumference were obtained. A modified questionnaire on symptoms of pelvic floor dysfunction was filled by the patients in both visits. vaginal examination with the women to detect any pelvic organ prolapse (quantified according to POP-Q classification system.

All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GE Voluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3D/4D ultrasound transducer. After emptying the bladder, ultrasound was done while the patient in the supine position. The probe was covered with clean glove adjusted and wrapped with an adhesive tape to make it firmly contacted to the probe and then placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Two 3D volumes (one with the patient at rest and one during Valsalva maneuver) were recorded.

Eligibility criteria: Inclusion Criteria:

* Primipara who had singleton fetus with cephalic presentation were recruited during their first post-partum visit ,1week post-delivery.

Exclusion Criteria:

Multi para, Multifetal pregnancy, congenital anomalies of the genital tract past history of pelvic floor surgery or trauma or inability to come for follow up after 6weeks

Primary outcomes:
measure: 1. maximum diameters of the levator hiatus , pubovisceral muscle thickness Levator avulsion .
timeFrame: 6weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shatby Maternity University Hospital
state: El-Khartoum Square
Study officials:
affiliation: Assistant professor
name: Mervat AM Elsersy, MD
role: PRINCIPAL_INVESTIGATOR
References: