Evaluation of Levator Injuries Using Transvaginal Endosonography (ELITE)

Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery.

In none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images.

3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles.

The relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term.

The principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.

Study Overview

• Status: Completed
• Conditions: Childbirth Related Levator Injuries

• Study Type: Observational
• Enrollment (Actual): 269

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Croydon, Surrey, United Kingdom, CR7 7YE
      • Croydon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Nulliparous

Description

Inclusion Criteria:

1. Pregnant women who have not delivered previously
2. Singleton pregnancy
3. Maternal age > 18 years and
4. No previous pregnancies >20 weeks of gestation
5. Ability to read and understand English.

Exclusion Criteria:

1. Pregnant women who have delivered previously
2. Multiple pregnancies

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Nulliparous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.	Antenatal, after delivery and postnatal

Collaborators and Investigators

• Sponsor: Croydon University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (Estimate): March 8, 2011

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 10/H0806/87