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OpenTrials
Completed

NCT Number: NCT03472521

Prevention of Persistent Opioid Use in Mothers

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.

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Key information

Conditions

Opioid Use Chronic Pain Syndrome Female Urogenital Diseases and Pregnancy Complications Postpartum Disorder Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Opiate use disorder

Treatment and study plan

Gabapentin

Drug

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

Drug

Placebo to match gabapentin

Primary outcomes

  1. Time to Opioid Cessation as a Measure of Opioid Utilization

    Time frame: Up to 12 weeks

Secondary outcomes

  1. 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).

  2. 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.

Other outcomes

  1. Fatigue

    Time frame: 12 weeks

    PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

  2. Depression

    Time frame: 12 weeks

    PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

  3. Anxiety

    Time frame: 12 weeks

    PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

  4. 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.

  5. Steps

    Time frame: 12 weeks after delivery

    Fitness tracker measured steps

  6. Sleep

    Time frame: 12 weeks after delivery

    Fitness tracker measured sleep

  7. Heart Rate

    Time frame: 12 weeks after delivery

    Fitness tracker measured heart rate

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Prevention of Persistent Pain and Opioid Use in Mothers - POMS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 21, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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