Clinical trial NCT02952404: Incidence of Obstetric Anal Sphincter Injuries After a Protection Training
Official title: Incidence of Obstetric Anal Sphincter Injuries After Training to Protect the Perineum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Trauma
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resident patients, 18 years and older women, who delivered vaginally between October 2014 and December 2016.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Obstetrics resident patients
* 18 years and older women who delivered vaginally between Oct. 2014 and Dec.2016

Exclusion Criteria:

* Women who delivered by cesarean section, preterm deliveries (less than 32 weeks), and multiple gestations

Primary outcomes:
measure: Incidence of obstetric anal sphincter injuries
timeFrame: before (between Oct. 2014 and Oct. 2015) and after (between Dec. 2015 and Dec. 2016_) an educational workshop (Nov. 2015)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References: