Evaluation of Levator Injuries Using Transvaginal Endosonography

NCT01310660 | Completed

• 1 other identifier: 10/H0806/87
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Childbirth Related Levator Injuries

Outcome Measures

Primary Outcomes (1)

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

  Antenatal, after delivery and postnatal

Study Arms (1)

Nulliparous

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Nulliparous

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women who have delivered previously
• Multiple pregnancies

Sponsors & Collaborators

• Croydon University Hospital: lead

Study Sites (1)

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urogynaecologist

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

GB (1)