Status:
COMPLETED
Postoperative Dexamethasone on Post-Cesarean Pain
Lead Sponsor:
Yale University
Conditions:
Post-Cesarean Pain
Cesarean Section Complications
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
For this study, the researchers are most interested in an option that would be able to be administered consistently (same time/same way): that labor nurses could give and without requiring the patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04067609
Start Date
July 20 2020
End Date
April 1 2024
Last Update
May 16 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510