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Pregnancy RelatedPhase 3PACTNCT04296396

Opioid Prescription After Cesarean Trial

A Phase 3 study testing 0 to 20 tablets of oxycodone 5mg and Fixed opioid prescription in people with Pregnancy Related and Opioid Use, run by The George Washington University Biostatistics Center at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Pregnancy Related, Opioid Use, Pain
What is being tested?
0 to 20 tablets of oxycodone 5mg and Fixed opioid prescription
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,521 participants
Where
12 sitesUnited States
Study dates
21 Sep 2020to 8 Jul 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • University of North Carolina-Chapel Hill

    Chapel Hill, North Carolina, 17599

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western Reserve-Metrohealth

    Cleveland, Ohio, 44109

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • University of Texas - Houston

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Brown Univeristy

    Providence, Rhode Island, 02905

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Prescription After Cesarean Trial

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.

Read the detailed description

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.

Being tested
0 to 20 tablets of oxycodone 5mg, Fixed opioid prescription
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0 to 20 tablets of oxycodone 5mgDrug

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

  • Fixed opioid prescriptionDrug

    20 tablets of oxycodone 5mg

Study groups in NCT04296396
Study groupRoleWhat they receive
Individualized Opioid PrescriptionExperimentalIndividualized opioid prescription protocol and shared decision making
Receives: Drug: 0 to 20 tablets of oxycodone 5mg
Fixed Opioid PrescriptionOtherFixed opioid prescription of 20 tablets of oxycodone 5mg
Receives: Drug: Fixed opioid prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 week post hospital discharge

Secondary outcomes (9)

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

    Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum

    Measured: After hospital discharge and up to 90 days postpartum

  2. Number of Opioid Prescriptions Filled

    Number of opioid prescriptions filled by ninety days postpartum

    Measured: 90 days postpartum

  3. Number of Opioid Tablets Unused Since Discharge

    Number of opioid tablets unused from discharge to 90 days postpartum

    Measured: 90 days postpartum

  4. Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge

    Total morphine milligram equivalents (MME) used from discharge to 2 weeks post-discharge. MME is the amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength.

    Measured: 2 weeks post discharge

  5. Worst Pain Severity Score at 2 Weeks Post Discharge

    Pain severity scores assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge. 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.

    Measured: 2 weeks post discharge

  6. Pain Interference Score ≥ 4 at 2 Weeks Post Discharge

    Pain interference scores ≥ 4 on the Brief Pain Inventory (numeric scale from 0 to 10) at 2 weeks post-discharge. 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. This outcome asks participants to indicate their pain scores for the week prior to completing the inventory.

    Measured: 2 weeks post discharge

  7. Number of Participants Who Indicated an Improved Global Impression of Change

    Number of participants who indicated an improved global impression of change in overall pain at 2 weeks post-discharge. This represents a selection on a multiple choice survey question with the response options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

    Measured: 2 weeks post discharge

  8. Infant Hospital Readmissions

    Proportion of infants readmitted to the hospital

    Measured: 6 weeks postpartum

  9. Maternal Depression Score ≥ 13

    The proportion of participants with a score of 13 or higher on the Edinburgh Postnatal Depression Scale. The minimum score is 0 and the maximum score is 30. Higher scores indicate worse outcomes, where persons scoring about 13 are likely to be suffering from a depressive illness. The scale indicates how the respondent has felt during the previous week.

    Measured: 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start21 Sep 2020
  3. Primary completion7 Apr 2022
  4. Study completion8 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296396
Sponsor's protocol ID
HD036801-PACT
Other IDs
U24HD036801, UG1HD087230, UG1HD027869, UG1HD027915, UG1HD034208, UG1HD040500, UG1HD040485, UG1HD053097
Acronym
PACT
Status last verified
Sep 2023
First submitted
3 Mar 2020
Last updated
3 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38857509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 0 to 20 tablets of oxycodone 5mg and Fixed opioid prescription in people with Pregnancy Related and Opioid Use, run by The George Washington University Biostatistics Center at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory (time frame: 1 week post hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296396, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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