Phase 4
N=24
Postoperative Dexamethasone on Post-Cesarean Pain
Post-Cesarean Pain · Cesarean Section Complications
Bottom Line
View on ClinicalTrials.gov: NCT04067609 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Mean Pain Score — 4.1; 4.2; 5.1; 5.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Score |
4.1; 4.2; 5.1; 5.2; 4.6; 4.5 | — |
| SECONDARY Change of Morphine Use |
32.3; 34.4; 38.3; 44.5; 14.3; 20.6 | — |
Summary
Investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.
Eligibility Criteria
Inclusion Criteria
- English-speaking,
- History of opioid use disorder with current use of MAT during pregnancy,
- Scheduled for cesarean delivery for their current pregnancy for any indication [examples of elective c-section (decision made for c-section to be performed prior to onset of labor): fetal malpresentation, suspected macrosomia, prior c-section, abnormal placentation, patient preference],
- Negative toxicology screen upon admission to the hospital for their cesarean section, no prior administration of betamethasone for fetal lung maturity within 24h of their scheduled cesarean delivery
Exclusion Criteria
- non-english speaking,
- screen positive for illicit substance(s) on their admission toxicology screen,
- require general anesthesia for their cesarean section due to maternal/fetal indication for non-anticipated urgency (thus no longer 'elective') or failure of adequate intra- operative pain control with spinal anesthesia,
- medical history including known cardiovascular disease, heart failure, uncontrolled hypertension, uncontrolled gestational diabetes or uncontrolled pregestational diabetes, active GI bleed or untreated peptic ulcer,
- untreated infectious diseases including tuberculosis, systemic candida
Data sourced from ClinicalTrials.gov (NCT04067609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.