Evaluation of Levator Injuries Using Transvaginal Endosonography (ELITE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Croydon University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ranee Thakar, Croydon University Hospital
ClinicalTrials.gov Identifier:
NCT01310660
First received: March 7, 2011
Last updated: April 5, 2012
Last verified: April 2012
  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

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 255
Study Start Date: January 2011
Groups/Cohorts
Nulliparous

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310660

Locations
United Kingdom
Croydon University Hospital Recruiting
Croydon, Surrey, United Kingdom, CR7 7YE
Contact: Ranee Thakar, MD MRCOG    00442084013154    raneethakar@yahoo.co.uk   
Sponsors and Collaborators
Croydon University Hospital
  More Information

No publications provided

Responsible Party: Ranee Thakar, Consultant Urogynaecologist, Croydon University Hospital
ClinicalTrials.gov Identifier: NCT01310660     History of Changes
Other Study ID Numbers: 10/H0806/87
Study First Received: March 7, 2011
Last Updated: April 5, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 27, 2014