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Evaluation of Levator Injuries Using Transvaginal Endosonography (ELITE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310660
First Posted: March 8, 2011
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ranee Thakar, Croydon University Hospital
  Purpose

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.


Condition
Childbirth Related Levator Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Levator Injuries Using Transvaginal Endosonography

Resource links provided by NLM:


Further study details as provided by Ranee Thakar, Croydon University Hospital:

Primary Outcome Measures:
  • The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. [ Time Frame: Antenatal, after delivery and postnatal ]

Enrollment: 269
Study Start Date: January 2011
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nulliparous

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nulliparous
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310660


Locations
United Kingdom
Croydon University Hospital
Croydon, Surrey, United Kingdom, CR7 7YE
Sponsors and Collaborators
Croydon University Hospital
  More Information

Responsible Party: Ranee Thakar, Consultant Urogynaecologist, Croydon University Hospital
ClinicalTrials.gov Identifier: NCT01310660     History of Changes
Other Study ID Numbers: 10/H0806/87
First Submitted: March 7, 2011
First Posted: March 8, 2011
Last Update Posted: February 1, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Wounds and Injuries