Status:

COMPLETED

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Lead Sponsor:

Northwestern University

Conditions:

Pain

Postpartum Depression

Eligibility:

FEMALE

18+ years

Phase:

PHASE4

Brief Summary

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of...

Eligibility Criteria

Inclusion

  • Age \>18 years of age
  • English-speaking
  • Vaginal delivery (spontaneous or assisted)
  • A full-term fetus (\>37 weeks' gestation)
  • OASIS as assessed by obstetrical provider
  • Functional epidural analgesia at time of delivery
  • Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

Exclusion

  • Previous pelvic surgery
  • History of chronic pelvic pain
  • History of recurrent urinary tract infections
  • Women with known malformations of their urinary tract
  • True allergies to ketamine and/or morphine
  • Preeclampsia or hypertensive disorder at the time of delivery
  • Obstructive sleep apnea

Key Trial Info

Start Date :

June 27 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 20 2024

Estimated Enrollment :

67 Patients enrolled

Trial Details

Trial ID

NCT03470675

Start Date

June 27 2018

End Date

June 20 2024

Last Update

December 9 2025

Active Locations (1)

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1

Northwestern University

Chicago, Illinois, United States, 60611