Trial · NCT04296396
Opioid Prescription After Cesarean Trial
NCT04296396, Phase 3, Completed, The George Washington University Biostatistics Center; results first posted 2023-10-03
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Opioid Prescription After Cesarean Trial. Trials, record NCT04296396. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04296396
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Opioid Prescription After Cesarean Trial
- NCT number
- NCT04296396
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,521 participants, actual
- Lead sponsor
- The George Washington University Biostatistics Center
- Conditions
- Pregnancy Related, Opioid Use, Pain
- Interventions
- 0 to 20 tablets of oxycodone 5mg, Fixed opioid prescription
- First posted
- 2020-03-05
- Last updated
- 2023-10-03
- Results first posted
- 2023-10-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | 1 week post hospital discharge | 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. |
| Secondary | 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 participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum |
| Secondary | Number of Opioid Prescriptions Filled | 90 days postpartum | Number of opioid prescriptions filled by ninety days postpartum |
| Secondary | Number of Opioid Tablets Unused Since Discharge | 90 days postpartum | Number of opioid tablets unused from discharge to 90 days postpartum |
| Secondary | Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge | 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. |
| Secondary | Worst Pain Severity Score at 2 Weeks Post Discharge | 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. |
| Secondary | Pain Interference Score ≥ 4 at 2 Weeks Post Discharge | 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. |
| Secondary | Number of Participants Who Indicated an Improved Global Impression of Change | 2 weeks post discharge | 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. |
| Secondary | Infant Hospital Readmissions | 6 weeks postpartum | Proportion of infants readmitted to the hospital |
| Secondary | Maternal Depression Score ≥ 13 | 6 weeks postpartum | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | 1 week post hospital discharge | Of 2273 participants in the fixed group, 1 was enrolled in the study for a second pregnancy. Only the first pregnancy was included in the analysis. The primary analysis included participants who completed the highest pain in the last 24 hours on the Brief Pain Inventory at 1 week post-discharge. This data was missing for 230 participants in the individualized opioid prescription group and 219 participants in the fixed group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Of 2273 participants in the fixed group, 1 was enrolled in the study for a second pregnancy. Only the first pregnancy was included in the analysis. This data was missing for 94 participants in the individualized opioid prescription group and 76 participants in the fixed group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Opioid Prescriptions Filled | 90 days postpartum | 94 missing in the IOPP group. 75 missing in the fixed group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Opioid Tablets Unused Since Discharge | 90 days postpartum | Data were missing for 207 participants in the IOPP group and for 180 in the fixed group. | tablets | MEDIAN |
| SECONDARY | Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge | 2 weeks post discharge | morphine milligram equivalent | MEDIAN | |
| SECONDARY | Worst Pain Severity Score at 2 Weeks Post Discharge | 2 weeks post discharge | Data were missing for 234 participants in the IOPP group and for 286 in the fixed group | score on a scale | MEDIAN |
| SECONDARY | Pain Interference Score ≥ 4 at 2 Weeks Post Discharge | 2 weeks post discharge | Data were missing for 234 participants in the IOPP group and for 286 in the fixed group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Indicated an Improved Global Impression of Change | 2 weeks post discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Infant Hospital Readmissions | 6 weeks postpartum | 2856 and 2889. Data is missing for 102 neonates in the IOPP group and 92 neonates in the fixed opioid group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maternal Depression Score ≥ 13 | 6 weeks postpartum | data is missing for 252 participants in the IOPP group and 276 participants in the fixed prescription group | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | Individualized Opioid Prescription | 1497 | Participants | ||
| Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | Fixed Opioid Prescription | 1535 | Participants | ||
| Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge | Individualized Opioid Prescription | 200 | Participants | ||
| Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge | Fixed Opioid Prescription | 166 | Participants | ||
| Number of Opioid Prescriptions Filled | Individualized Opioid Prescription Protocol (IOPP) | Number of participants who filled zero prescriptions | 601 | Participants | |
| Number of Opioid Prescriptions Filled | Fixed Opioid Prescription | Number of participants who filled zero prescriptions | 452 | Participants | |
| Number of Opioid Prescriptions Filled | Individualized Opioid Prescription Protocol (IOPP) | Number of participants who filled one prescription | 1873 | Participants | |
| Number of Opioid Prescriptions Filled | Fixed Opioid Prescription | Number of participants who filled one prescription | 2086 | Participants | |
| Number of Opioid Prescriptions Filled | Individualized Opioid Prescription Protocol (IOPP) | Number of participants who filled 2 prescriptions | 163 | Participants | |
| Number of Opioid Prescriptions Filled | Fixed Opioid Prescription | Number of participants who filled 2 prescriptions | 140 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Individualized Opioid Prescription Protocol (IOPP) | 2,748 | |
| Overall Study | STARTED | Fixed Opioid Prescription | 2,773 | |
| Overall Study | COMPLETED | Individualized Opioid Prescription Protocol (IOPP) | 2,386 | |
| Overall Study | COMPLETED | Fixed Opioid Prescription | 2,426 | |
| Overall Study | NOT COMPLETED | Individualized Opioid Prescription Protocol (IOPP) | 362 | |
| Overall Study | NOT COMPLETED | Fixed Opioid Prescription | 347 |
Source ClinicalTrials.gov
Adverse events272
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | General disorders | Individualized Opioid Prescription (IOPP) -Mother | 166 | 2,748 | 166 |
| other | Drowsiness | General disorders | Fixed Opioid Prescription -Mother | 186 | 2,772 | 186 |
| other | Drowsiness | General disorders | Individualized Opioid Prescription (IOPP) -Neonates/Infants | 0 | 2,856 | 0 |
| other | Drowsiness | General disorders | Fixed Opioid Prescription - Neonates/Infants | 0 | 2,889 | 0 |
| serious | Bradycardia | Cardiac disorders | Individualized Opioid Prescription (IOPP) -Mother | 1 | 2,748 | 1 |
| serious | Bradycardia | Cardiac disorders | Fixed Opioid Prescription -Mother | 0 | 2,772 | 0 |
| serious | Bradycardia | Cardiac disorders | Individualized Opioid Prescription (IOPP) -Neonates/Infants | 0 | 2,856 | 0 |
| serious | Bradycardia | Cardiac disorders | Fixed Opioid Prescription - Neonates/Infants | 0 | 2,889 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Individualized Opioid Prescription (IOPP) -Mother | 0 | 2,748 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Fixed Opioid Prescription -Mother | 1 | 2,772 | 1 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Individualized Opioid Prescription (IOPP) -Mother | 0 | 2,748 |
| Total, all-cause mortality | Fixed Opioid Prescription -Mother | 0 | 2,772 |
| Total, all-cause mortality | Individualized Opioid Prescription (IOPP) -Neonates/Infants | 11 | 2,856 |
| Total, all-cause mortality | Fixed Opioid Prescription - Neonates/Infants | 8 | 2,889 |
| Total, other adverse events | Individualized Opioid Prescription (IOPP) -Mother | 166 | 2,748 |
| Total, other adverse events | Fixed Opioid Prescription -Mother | 186 | 2,772 |
| Total, other adverse events | Individualized Opioid Prescription (IOPP) -Neonates/Infants | 0 | 2,856 |
| Total, other adverse events | Fixed Opioid Prescription - Neonates/Infants | 0 | 2,889 |
| Total, serious adverse events | Individualized Opioid Prescription (IOPP) -Mother | 133 | 2,748 |
| Total, serious adverse events | Fixed Opioid Prescription -Mother | 96 | 2,772 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38857509 | DERIVED |
Source PubMed
Grants13
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24HD036801 | NICHD Maternal-Fetal Medicine Units (MFMU) Network: Data CoordinatingCenter | CLIFTON, REBECCA GERSNOVIEZ | GEORGE WASHINGTON UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2021 to 2025 | NIH RePORTER |
| UG1HD027869 | Maternal-Fetal Medicine Units (MFMU) Network | TITA, ALAN THEVENET N. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD027915 | NICHD maternal fetal medicine units network | COSTANTINE, MAGED | OHIO STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD034208 | UofU Maternal-Fetal Medicine Units (MFMU) Network: Clinical Centers | METZ, TORRI D | UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040485 | Columbia University Maternal-Fetal Medicine Units Network Clinical Center | ZORK, NOELIA MILENA MODAD | COLUMBIA UNIVERSITY HEALTH SCIENCES | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040500 | Brown University/Women & Infants Hospital of Rhode Island (WIH) Center Application for the Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network | ROUSE, DWIGHT J | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040512 | Maternal Fetal Medicine Units Network - Northwestern Study Center | YEE, LYNN M | NORTHWESTERN UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040544 | Case Western Reserve University Center of the NICHD MFMU Network | GIBSON, KELLY S; RANZINI, ANGELA C. | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040545 | Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network (UG1) | MENDEZ-FIGUEROA, HECTOR | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040560 | UNC MFMU: Advancing Perinatal Health via Definitive, Multi-Site Clinical Studies | THORP, JOHN M | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
1 to 10 of 13
See all 13 grantsTrial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Individualized Opioid Prescription vs Fixed Opioid Prescription: Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge | Trial comparisons |
| Individualized Opioid Prescription vs Fixed Opioid Prescription: Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | Trial comparisons |
| Individualized Opioid Prescription (IOPP) -Neonates/Infants vs Fixed Opioid Prescription - Neonates/Infants: Infant Hospital Readmissions | Trial comparisons |
| Individualized Opioid Prescription Protocol (IOPP) vs Fixed Opioid Prescription: Maternal Depression Score ≥ 13 | Trial comparisons |
| Individualized Opioid Prescription Protocol (IOPP) vs Fixed Opioid Prescription: Pain Interference Score ≥ 4 at 2 Weeks Post Discharge | Trial comparisons |
| Individualized Opioid Prescription Protocol (IOPP) vs Fixed Opioid Prescription: Number of Participants Who Indicated an Improved Global Impression of Change | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04296396
GET https://conductscience.org/api/trials/v1/NCT04296396/results?page=2