Anal Sphincter InjuryAnaSphRFNCT01310426
Risk Factors for Anal Sphincter Damage During Vaginal Delivery
An observational study of Anal Sphincter Injury and Fecal Incontinence, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Read more about this study
- Who is it for?
- Ages 17 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Sphincter Injury, Fecal Incontinence
- What is being tested?
- 3D transperineal Ultrasound
- How many people
- 33 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Mar 2014
- 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 17 to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study population are women between ages 17 and 40 after their first delivery at the Hadassa Mount Scopus hospital in Jerusalem, Israel.
Who may be able to join
- First Delivery
- Vaginal Delivery
- Birthweight > 3000
- Singleton pregnancy
Who cannot join
- Anal sphincter disruption before birth
Trial locations and contacts
1 site in 1 country.
About this study
Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US).
- Conditions
- Anal Sphincter Injury, Fecal Incontinence
- Being tested
- 3D transperineal Ultrasound
- Keywords
- Anal Sphincter injury, Fecal Incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D transperineal UltrasoundOther
3D transperineal Ultrasound after vaginal delivery
| Study group | Role | What they receive |
|---|---|---|
| anal sphincter damage | After assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without. Receives: Other: 3D transperineal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal sphincter damage
Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery
Measured: up to one year after vaginal birth
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 startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drorith Hochner, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310426
- Sponsor's protocol ID
- AnaSphRF-HMO-CTIL
- Acronym
- AnaSphRF
- Status last verified
- Jul 2015
- First submitted
- 1 Mar 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Anal Sphincter Damage During Vaginal Delivery
- ClinicalTrials.gov ID
- NCT01310426
- Acronym / sponsor ID
- AnaSphRF / AnaSphRF-HMO-CTIL
- Conditions
- Anal Sphincter Injury, Fecal Incontinence
- Keywords
- Anal Sphincter injury, Fecal Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (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.
Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anal sphincter damage | – | Other: 3D transperineal UltrasoundAfter assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without. |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population are women between ages 17 and 40 after their first delivery at the Hadassa Mount Scopus hospital in Jerusalem, Israel.
Key inclusion criteria (4 listed)
- First Delivery
- Vaginal Delivery
- Birthweight > 3000
- Singleton pregnancy
Key exclusion criteria (1 listed)
- Anal sphincter disruption before birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D transperineal Ultrasound3D transperineal Ultrasound after vaginal delivery | Other | anal sphincter damage |
Primary outcome
Anal sphincter damage
Time frame: up to one year after vaginal birth
Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery
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 28 Jul 2015.
Related trials for Anal Sphincter Injury
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Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
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Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Recruiting
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Postpartum Quality of Life, Peripartal Maternal Trauma
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Drorith Hochner, MD principal investigator
Hadassah Medical Organization
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 Anal Sphincter Injury and Fecal Incontinence, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 1 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 28 Jul 2015. 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 Israel. 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?
Anal sphincter damage (time frame: up to one year after vaginal birth). 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 28 Jul 2015.