Obstetric TraumaNCT02952404
Incidence of Obstetric Anal Sphincter Injuries After a Protection Training
An observational study of Obstetric Trauma, run by TriHealth Inc. at 1 site in United States.
Trial summary
This is a retrospective cohort study. This two cohort study seeks to compare the incidence of obstetric anal sphincter injuries (OASIS) in two time periods, before and after an educational workshop for improved perineal support. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Trauma
- What is being tested?
- Educational workshop
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Resident patients, 18 years and older women, who delivered vaginally between October 2014 and December 2016.
Who may be able to join
- Obstetrics resident patients
- 18 years and older women who delivered vaginally between Oct. 2014 and Dec.2016
Who cannot join
- Women who delivered by cesarean section, preterm deliveries (less than 32 weeks), and multiple gestations
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: Incidence of Obstetric Anal Sphincter Injuries After Training to Protect the Perineum
This is a retrospective cohort study. This two cohort study seeks to compare the incidence of obstetric anal sphincter injuries (OASIS) in two time periods, before and after an educational workshop for improved perineal support.
Read the detailed description
Perineal trauma during vaginal delivery is a major health issue associated with significant morbidity. It has been associated with many long term sequelae, including urinary and fecal incontinence. Specifically, third and fourth degree lacerations are known risk factors for the development of fecal incontinence.
Due to their serious impact, third or fourth degree perineal tears are a commonly tracked adverse event in obstetric care (Agency for Healthcare Research and Quality and Joint Commission). As such, incidence data will soon be available to third-party payers and to the public on the Internet. Moreover, functional impairment after perineal lacerations continues to be a significant impetus for legal claims. Thus, reducing OASIS while preserving maternal and fetal outcomes is an important goal in clinical obstetrics.
At the two TriHealth tertiary care institutions, the overall rate of OASIS is 3.5%. This is comparable, but not superior, to published rates at other centers. In fact, the literature is quite variable, with reported incidences ranging from 0.25-6%. Indeed, TriHealth has recently set up a task force to reduce these injuries as part of recent endeavors for quality improvement. Prevention is the first step in improving these complications.
This study seeks to decrease the incidence of obstetric and anal sphincter injuries that may occur during the birthing process by bringing in a notable physician to review techniques with the obstetrics residents to help avoid these injuries then observe the deliveries of the women enrolled.
- Conditions
- Obstetric Trauma
- Being tested
- Educational workshop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational workshopProcedure or surgery
The educational workshop for improved perineal support during vaginal delivery
| Study group | Role | What they receive |
|---|---|---|
| Before workshop | October 2014 to October 2015 Cohort which is the time frame before the educational workshop | |
| After workshop | December 2015 to December 2016 Cohort which is the time after the educational workshop Receives: Procedure: Educational workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of obstetric anal sphincter injuries
This is identified by ICD-9 code of third or fourth degree lacerations.
Measured: before (between Oct. 2014 and Oct. 2015) and after (between Dec. 2015 and Dec. 2016_) an educational workshop (Nov. 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric TraumaStudies 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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952404
- Sponsor's protocol ID
- 15-050
- Status last verified
- Jan 2018
- First submitted
- 31 Oct 2016
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Obstetric Anal Sphincter Injuries After Training to Protect the Perineum
- ClinicalTrials.gov ID
- NCT02952404
- Acronym / sponsor ID
- 15-050
- Conditions
- Obstetric Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Nov 2016 (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.
This is a retrospective cohort study. This two cohort study seeks to compare the incidence of obstetric anal sphincter injuries (OASIS) in two time periods, before and after an educational workshop for improved perineal support.
Detailed description
Perineal trauma during vaginal delivery is a major health issue associated with significant morbidity. It has been associated with many long term sequelae, including urinary and fecal incontinence. Specifically, third and fourth degree lacerations are known risk factors for the development of fecal incontinence.
Due to their serious impact, third or fourth degree perineal tears are a commonly tracked adverse event in obstetric care (Agency for Healthcare Research and Quality and Joint Commission). As such, incidence data will soon be available to third-party payers and to the public on the Internet. Moreover, functional impairment after perineal lacerations continues to be a significant impetus for legal claims. Thus, reducing OASIS while preserving maternal and fetal outcomes is an important goal in clinical obstetrics.
At the two TriHealth tertiary care institutions, the overall rate of OASIS is 3.5%. This is comparable, but not superior, to published rates at other centers. In fact, the literature is quite variable, with reported incidences ranging from 0.25-6%. Indeed, TriHealth has recently set up a task force to reduce these injuries as part of recent endeavors for quality improvement. Prevention is the first step in improving these complications.
This study seeks to decrease the incidence of obstetric and anal sphincter injuries that may occur during the birthing process by bringing in a notable physician to review techniques with the obstetrics residents to help avoid these injuries then observe the deliveries of the women enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before workshop | – | –October 2014 to October 2015 Cohort which is the time frame before the educational workshop |
| After workshop | – | Procedure: Educational workshopDecember 2015 to December 2016 Cohort which is the time after the educational workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Resident patients, 18 years and older women, who delivered vaginally between October 2014 and December 2016.
Key inclusion criteria (2 listed)
- Obstetrics resident patients
- 18 years and older women who delivered vaginally between Oct. 2014 and Dec.2016
Key exclusion criteria (1 listed)
- Women who delivered by cesarean section, preterm deliveries (less than 32 weeks), and multiple gestations
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 |
|---|---|---|
| Educational workshopThe educational workshop for improved perineal support during vaginal delivery | Procedure or surgery | After workshop |
Primary outcome
Incidence of obstetric anal sphincter injuries
Time frame: before (between Oct. 2014 and Oct. 2015) and after (between Dec. 2015 and Dec. 2016_) an educational workshop (Nov. 2015)
This is identified by ICD-9 code of third or fourth degree lacerations.
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 23 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
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 Obstetric Trauma, run by TriHealth Inc. at 1 site in United States.
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 2 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 23 Jan 2018. 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 States. 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?
Incidence of obstetric anal sphincter injuries (time frame: before (between Oct. 2014 and Oct. 2015) and after (between Dec. 2015 and Dec. 2016_) an educational workshop (Nov. 2015)). 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 23 Jan 2018.