Evaluation of Levator Ani Muscle Injury in Primiparous

NCT ID: NCT04980235

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 355 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2021-08-15

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.

Conditions

Pelvic Floor Disorders

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

transperineal 3D ultrasound

All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GEVoluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3Dultrasound transducer

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Mervit Sersy

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mervat AM Elsersy, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Locations

Shatby Maternity University Hospital

Alexandria, El-Khartoum Square, Egypt

Countries

Egypt

Other Identifiers

0305043

Identifier Type: -

Identifier Source: org_study_id