NCT04296396

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,521

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

March 3, 2020

Results QC Date

April 10, 2023

Last Update Submit

September 6, 2023

Conditions

Pregnancy RelatedOpioid UsePain

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory

    Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the "Worst Pain" question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.

    1 week post hospital discharge

Secondary Outcomes (9)

  • Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge

    After hospital discharge and up to 90 days postpartum

  • Number of Opioid Prescriptions Filled

    90 days postpartum

  • Number of Opioid Tablets Unused Since Discharge

    90 days postpartum

  • Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge

    2 weeks post discharge

  • Worst Pain Severity Score at 2 Weeks Post Discharge

    2 weeks post discharge

  • +4 more secondary outcomes

Study Arms (2)

Individualized Opioid Prescription

EXPERIMENTAL

Individualized opioid prescription protocol and shared decision making

Drug: 0 to 20 tablets of oxycodone 5mg

Fixed Opioid Prescription

OTHER

Fixed opioid prescription of 20 tablets of oxycodone 5mg

Drug: Fixed opioid prescription

Interventions

0 to 20 tablets of oxycodone 5mgDRUG

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

Individualized Opioid Prescription
Fixed opioid prescriptionDRUG

20 tablets of oxycodone 5mg

Fixed Opioid Prescription

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 17599, United States

Location

Case Western Reserve-Metrohealth

Cleveland, Ohio, 44109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown Univeristy

Providence, Rhode Island, 02905, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • 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.

    PMID: 38857509DERIVED

MeSH Terms

Conditions

Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
MFMU Principal Investigator
Organization
George Washington University Biostatistics Center
mfmudatasets@bsc.gwu.edu
301-881-9260

Study Officials

  • Monica Longo, MD

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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

September 21, 2020

Primary Completion

April 7, 2022

Study Completion

July 8, 2022

Last Updated

October 3, 2023

Results First Posted

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The dataset will be shared per NIH policy after the completion and publication of the main analyses. Data will be available through the NICHD Data and Specimen Hub.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(12)