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Clinical Trials/NCT01310660
NCT01310660CompletedNot Applicable

Evaluation of Levator Injuries Using Transvaginal Endosonography

Croydon University Hospital1 site in 1 country269 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
269
Locations
1
Primary Endpoint
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Time Frame: Antenatal, after delivery and postnatal

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Croydon University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ranee Thakar

Consultant Urogynaecologist

Croydon University Hospital

Study Sites (1)

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