# Prescription After CesareanTrial - (PACT) MFMU Supplement

> **NIH NIH U24** · GEORGE WASHINGTON UNIVERSITY · 2021 · $550,000

## Abstract

PROJECT SUMMARY
Cesarean delivery is the most commonly performed major surgical procedure in the United States. Systemic
opioids have been universally used for post-cesarean analgesia management, with the number of tablets
prescribed varying significantly between providers and institutions. Pain thresholds and analgesic requirements
vary between patients, and studies suggest that most women are given prescriptions for at least 10 more
tablets at discharge than needed. The consequence of over-prescribing opioids for 1.2 million cesareans
annually is 12.5 million unused tablets. These unused tablets often go unguarded, and undisposed, providing
an important reservoir of opioids that may be misused, diverted or accidentally ingested, contributing to the
opioid crisis. The one-size-fits-all approach to pain management is clearly suboptimal. Some women may not
even need opioids: one small study reported that pain scores were higher among women who were prescribed
opioids than those who were prescribed ibuprofen and acetaminophen. While recent studies have evaluated
opioid prescribing practices, there are limited data on the effect of using an individualized opioid prescription
protocol following a cesarean delivery.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal Fetal
Medicine Units (MFMU) Network proposes a non-inferiority multi-center unblinded randomized trial of 5,500
women undergoing a cesarean delivery who are randomized before discharge to either an individualized opioid
prescription protocol (IOPP) that includes shared decision-making or to a fixed opioid prescription of 20 tablets
of oxycodone 5mg which approximates current standard of care at the participating institutions. The primary
aim is to evaluate whether IOPP with shared decision-making is not inferior to a fixed opioid prescription of 20
tablets of oxycodone 5mg in pain management defined as the presence/absence of moderate to severe pain at
1 week after discharge. Secondary aims will evaluate whether IOPP with shared decision making 1)
decreases an opioid refill prescription, 2) decreases the total amount of opioid tablets prescribed and the total
morphine milligram equivalents used, 3) has equivalent pain intensity and interference, and satisfactions
scores, and 4) reduces adverse maternal and infant outcomes.

## Key facts

- **NIH application ID:** 10434255
- **Project number:** 3U24HD036801-24S1
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Rebecca Gersnoviez Clifton
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $550,000
- **Award type:** 3
- **Project period:** 2021-07-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10434255

## Citation

> US National Institutes of Health, RePORTER application 10434255, Prescription After CesareanTrial - (PACT) MFMU Supplement (3U24HD036801-24S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10434255. Licensed CC0.

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