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CompletedPhase 4Results posted

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

NCT03470675 · Northwestern University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
67
Target enrolment
1
Study sites
1 US states

What it is testing

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 the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS. This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS. The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.

    Measured over 1 week after vaginal delivery

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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 Criteria: * 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

Where

1 study site

FacilityCityRegionCountry
Northwestern UniversityChicagoIllinoisUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03470675 on ClinicalTrials.gov →

Last updated in the registry 2026-04-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 3 trials from Northwestern University →