NCT02952404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

October 31, 2016

Last Update Submit

January 22, 2018

Conditions

Obstetric Trauma

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

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

Procedure: Educational workshop

Interventions

Educational workshopPROCEDURE

The educational workshop for improved perineal support during vaginal delivery

After workshop

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Resident patients, 18 years and older women, who delivered vaginally between October 2014 and December 2016.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Study Officials

  • Rachel Pauls, MD

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)