Phase 4
Completed N=78
Prevention of Persistent Opioid Use in Mothers
Opioid Use Disorder · Postpartum Disorder · Chronic Pain Syndrome
Source: ClinicalTrials.gov NCT03472521 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Time to Opioid Cessation as a Measure of Opioid Utilization — 2; 2 weeks
◆ Published Evidence
Emerging
5citations · ~2 / year
Outpatient Treatment With Gabapentin in Women With Severe Acute Pain After Cesarean Delivery Is Ineffective: A Randomized, Double-Blind, Placebo-Controlled Trial.
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.
Linked Publications
-
Outpatient Treatment With Gabapentin in Women With Severe Acute Pain After Cesarean Delivery Is Ineffective: A Randomized, Double-Blind, Placebo-Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Opioid Cessation as a Measure of Opioid Utilization |
2; 2 | — |
| SECONDARY Pain Report |
7; 12 | — |
| SECONDARY Functional Recovery |
8; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Delivery within 5 days, able to provide informed consent, English speaker
Exclusion Criteria
- Opiate use disorder
Data sourced from ClinicalTrials.gov (NCT03472521) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.