Opioid Prescription After Cesarean Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5521 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2022-07-08

Brief Summary

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Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to 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.

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Detailed Description

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This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were 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. The primary endpoint was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women were assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization was stratified by site. Women were followed through 90 days postpartum.

Conditions

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Pregnancy Related Opioid Use Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomized 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Individualized Opioid Prescription

Individualized opioid prescription protocol and shared decision making

Group Type EXPERIMENTAL

0 to 20 tablets of oxycodone 5mg

Intervention Type DRUG

Individualized opioid prescription protocol (IOPP) that includes shared decision making

Fixed Opioid Prescription

Fixed opioid prescription of 20 tablets of oxycodone 5mg

Group Type OTHER

Fixed opioid prescription

Intervention Type DRUG

20 tablets of oxycodone 5mg

Interventions

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0 to 20 tablets of oxycodone 5mg

Individualized opioid prescription protocol (IOPP) that includes shared decision making

Intervention Type DRUG

Fixed opioid prescription

20 tablets of oxycodone 5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
* Singleton, twin or triplet gestation

Exclusion Criteria

* An opioid prescription filled during the current pregnancy
* Known history of opioid use disorder, by medical record review
* Contraindication to opioids (oxycodone)
* Contraindications to both acetaminophen and ibuprofen
* Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
* Fetal or neonatal death prior to randomization
* Inability to randomize within 1 day before planned discharge from the hospital
* Inability to participate in shared decision making as assessed by research staff
* Language barrier (non-English or Spanish speaking)
* Participation in this trial in a previous pregnancy
* Participation in another intervention study that influences the primary outcome in this trial

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monica Longo, MD

Role: STUDY_DIRECTOR

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Locations

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University of Alabama - Birmingham

Birmingham, Alabama, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Case Western Reserve-Metrohealth

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Brown Univeristy

Providence, Rhode Island, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

University of Texas - Houston

Houston, Texas, United States

Site Status

University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Smid MC, Clifton RG, Rood K, Srinivas S, Simhan HN, Casey BM, Longo M, Landau R, MacPherson C, Bartholomew A, Sowles A, Reddy UM, Rouse DJ, Bailit JL, Thorp JM Jr, Chauhan SP, Saade GR, Grobman WA, Macones GA; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Aug 1;144(2):195-205. doi: 10.1097/AOG.0000000000005649. Epub 2024 Jun 10.

Reference Type DERIVED

PMID: 38857509 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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