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NCT06285123 · ClinicalTrials.gov registry record
Implementing the COMFORT Guidelines for Postpartum Pain Management
A clinical trial of Postpartum Pain and Obstetric Care, sponsored by University of Michigan.
- Completed
- Registry status
- 69
- Enrollment target
- 1
- Study location
NCT06285123: Completed study of Postpartum Pain and Obstetric Care, sponsored by University of Michigan.
NCT06285123 is a study of Postpartum Pain and Obstetric Care that has completed, run by University of Michigan. The registered enrollment target is 69 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06285123, a study of Postpartum Pain and Obstetric Care, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change clinical practice-more active implementation efforts are generally required. Replicating Effective Programs (REP) is a theory-driven implementation intervention that is publicly available and highly scalable, but REP alone may be insufficient for effectively embedding the CPG across all maternity sites. For sites needing more support, REP can be augmented with facilitation (e.g., individualized consultation with site champions to overcome local barriers to CPG adoption, "Enhanced-REP" \[E-REP\]). Because E-REP is more expensive and difficult to scale than REP, it is essential to identify those settings where REP alone is effective versus those where REP may need augmentation, but this has not been evaluated in maternity contexts. Our objective is to determine the effect of a new postpartum pain management CPG, as implemented by REP and E-REP, on postpartum opioid prescribing (primary outcome: rate and amount of opioid prescribed within three days of childbirth), overall, by hospital, and among key subgroups. This is a non-responder randomized trial within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people over an approximately 15-month study time period. Hospitals not initially responding to REP (defined by performance below the top 15th percentile of all OBI hospitals for a) inpatient order for opioid-sparing postpartum pain management, \[e.g., scheduled acetaminophen and ibuprofen\], or b) amount of opioid prescribed at discharge, or c) provision of non-medication pain management interventions) will be allocated, via bloc
Primary Outcome
Rate of opioid prescribing within three days of discharge from the childbirth hospitalization
Conditions Studied
Interventions
- BEHAVIORAL REP
- BEHAVIORAL Facilitation
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-01-26 |
| Est. Completion | 2025-07-01 |
What the finished NCT06285123 record still lists
NCT06285123 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 69 participants, a relatively small participant target.
The record links to 4 conditions, with Postpartum Pain appearing as the primary indexed condition, and to 2 interventions - of which REP is the first listed.
NCT06285123 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06285123 about?
NCT06285123 is a clinical study titled "Implementing the COMFORT Guidelines for Postpartum Pain Management". A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change ...
What is the current status of trial NCT06285123?
This trial is currently completed. The enrollment target is 69 participants. The study started on 2024-01-26. Estimated completion is 2025-07-01.
What conditions does trial NCT06285123 study?
This clinical trial studies the following conditions: Postpartum Pain, Obstetric Care, Opioid Stewardship, Maternity Care.
What interventions are being tested in trial NCT06285123?
The interventions under investigation include: REP (BEHAVIORAL), Facilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06285123?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06285123 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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