Prevention of Persistent Opioid Use in Mothers

April 8, 2022 updated by: Stanford University

Prevention of Persistent Pain and Opioid Use in Mothers - POMS

Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A small percent of the large population of women who give birth have difficulty with prolonged pain, opioid use and poor functional recovery. This may be the first opiate exposure and significant health challenge in a young woman's life.

In our previous work, we have identified 20% who are at highest risk for prolonged pain and delayed opioid cessation and functional recovery with usual care. Moderate to severe pain on postpartum day 1 is a significant predictor of being in the risk group. The optimal intervention to mitigate this risk is unknown.

We plan to test an intervention of low dose gabapentin or placebo to be escalated by a pain medicine doctor as needed. We hypothesize that additional care of women predicted to be higher need by virtue of their postoperative day one pain score (> 6 x2) despite usual multimodal analgesic care will lead to reduced need for opioid, less pain and more rapid functional recovery.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Lucille Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Delivery within 5 days, able to provide informed consent, English speaker

Exclusion Criteria:

  • Opiate use disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin
Gabapentin 300 mg capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Drug: Gabapentin
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
Other Names:
  • Active
Placebo Comparator: Control
Matched placebo capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Drug: Placebo
Placebo to match gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Opioid Cessation as a Measure of Opioid Utilization
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Report
Time Frame: 12 weeks
Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).
12 weeks
Functional Recovery
Time Frame: 12 weeks
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 12 weeks
PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
12 weeks
Depression
Time Frame: 12 weeks
PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
12 weeks
Anxiety
Time Frame: 12 weeks
PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
12 weeks
PROMIS Physical Function
Time Frame: 12 weeks after delivery
PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.
12 weeks after delivery
Steps
Time Frame: 12 weeks after delivery
Fitness tracker measured steps
12 weeks after delivery
Sleep
Time Frame: 12 weeks after delivery
Fitness tracker measured sleep
12 weeks after delivery
Heart Rate
Time Frame: 12 weeks after delivery
Fitness tracker measured heart rate
12 weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Pamela Flood, MD, MA, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

April 10, 2021

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-43964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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