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Prevention of Persistent Opioid Use in Mothers

NCT03472521 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-05-05

Study results available
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Summary

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.

Conditions

  • Opioid Use
  • Postpartum Disorder
  • Chronic Pain Syndrome

Interventions

DRUG

Gabapentin

Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.

DRUG

Placebo

Placebo to match gabapentin

Sponsors & Collaborators

Principal Investigators

  • Pamela Flood, MD, MA · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2020-07-02
Completion
2021-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03472521 on ClinicalTrials.gov