Incidence of Obstetric Anal Sphincter Injuries After a Protection Training

Obstetric Trauma Clinical Trial

Official title:

Incidence of Obstetric Anal Sphincter Injuries After Training to Protect the Perineum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952404
• Other study ID #: 15-050
• Status: Completed
• Phase: N/A
• First received: October 31, 2016
• Last updated: January 22, 2018
• Start date: November 2015
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Trauma

Intervention

Procedure:
• Educational workshop
The educational workshop for improved perineal support during vaginal delivery

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of obstetric anal sphincter injuries	This is identified by ICD-9 code of third or fourth degree lacerations.	before (between Oct. 2014 and Oct. 2015) and after (between Dec. 2015 and Dec. 2016_) an educational workshop (Nov. 2015)