Skip to content

Evaluation of Levator Injuries Using Transvaginal Endosonography

Evaluation of Levator Injuries Using Transvaginal Endosonography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01310660
Acronym
ELITE
Enrollment
269
Registered
2011-03-08
Start date
2011-01-31
Completion date
Unknown
Last updated
2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth Related Levator Injuries

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.

Interventions

None listed

Sponsors

Croydon University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.Antenatal, after delivery and postnatal

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026