Childbirth Related Levator InjuriesELITENCT01310660
Evaluation of Levator Injuries Using Transvaginal Endosonography
An observational study of Childbirth Related Levator Injuries, run by Croydon University Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Related Levator Injuries
- How many people
- 269 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Nulliparous
Who may be able to join
- 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.
Who cannot join
- Pregnant women who have delivered previously
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Croydon University Hospital
Croydon, Surrey, CR7 7YE
About this study
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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.
Measured: Antenatal, after delivery and postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth Related Levator InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croydon University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranee Thakar, Croydon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310660
- Sponsor's protocol ID
- 10/H0806/87
- Acronym
- ELITE
- Status last verified
- Jan 2016
- First submitted
- 7 Mar 2011
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Levator Injuries Using Transvaginal Endosonography
- ClinicalTrials.gov ID
- NCT01310660
- Acronym / sponsor ID
- ELITE / 10/H0806/87
- Conditions
- Childbirth Related Levator Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Croydon University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nulliparous | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Nulliparous
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women who have delivered previously
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth.
Time frame: Antenatal, after delivery and postnatal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childbirth Related Levator Injuries, run by Croydon University Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. (time frame: Antenatal, after delivery and postnatal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.