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New study tests better pain relief for severe birth tears

NCT ID NCT03470675

Symptom relief Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at three ways to manage pain after severe perineal tears (called OASIS) that can happen during vaginal delivery. Sixty-seven women received either a placebo, epidural morphine alone, or epidural morphine plus intravenous ketamine. The goal was to see which option reduced pain one week after birth. The findings could help improve postpartum recovery for women with these injuries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epidural morphine and intravenous ketamine
What this could lead to
If effective, this could point toward a standard pain management approach for women with severe perineal tears after childbirth.
What could go wrong
This is a small, completed Phase 4 trial with only 67 participants, so results may not apply to all women. Pain relief from a single dose may be limited and side effects possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

67 people

The number who actually took part.

Started

Jun 2018

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pain postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain Postpartum depression

Contacts and locations

Locations

  • Northwestern University

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.