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OpenTrials
Completed

NCT Number: NCT04980235

Evaluation of Levator Ani Muscle Injury in Primiparous

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.

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Key information

Age range

19 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Shatby Maternity University Hospital

Alexandria, El-Khartoum Square, 21131, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transperineal 3D ultrasound

Diagnostic Test

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

Primary outcomes

  1. 1. maximum diameters of the levator hiatus , pubovisceral muscle thickness Levator avulsion .

    Time frame: 6weeks

    Measurements were performed in the axial plane at the level of 'minimal hiatal dimensions'

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: ULTRASOUND

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Sep 23, 2021

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.

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