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OpenTrials
Completed

NCT Number: NCT01310660

Evaluation of Levator Injuries Using Transvaginal Endosonography

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Pregnant women who have delivered previously
  • Multiple pregnancies

Treatment and study plan

Primary outcomes

  1. The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.

    Time frame: Antenatal, after delivery and postnatal

Sponsors and collaborators

Lead sponsor

Croydon University Hospital

Other

Registry information

Acronym: ELITE

Important dates

Study start
2011
Primary completion
2013
First posted
Mar 8, 2011
Registry last updated
Feb 1, 2016

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.