Evaluation of Levator Ani Muscle Injury in Primiparous (ULTRASOUND)

Evaluation of Levator Ani Muscle Injury in Primiparous Women at One and Six Weeks Postpartum Using 4D Transperineal Ultrasound: Comparative Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Diagnostic test: transperineal 3D ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• Egypt
  • El-Khartoum Square
    • Alexandria, El-Khartoum Square, Egypt, 21131
      • Shatby maternity university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. maximum diameters of the levator hiatus , pubovisceral muscle thickness Levator avulsion .	Measurements were performed in the axial plane at the level of 'minimal hiatal dimensions'	6weeks

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mervat AM Elsersy, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: levator hiatus
• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: 0305043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all individual participant data that underlie result
• IPD Sharing Time Frame: starting 6 months after publication).
• IPD Sharing Access Criteria: all individuals in the same institution
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No