Postoperative Dexamethasone on Post-Cesarean Pain

NCT04067609 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2000025968000
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 opioid use after cesarean section.

Conditions

Post-Cesarean Pain; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score

  Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).

  24, 48, 72 and 96 hours post-op

Secondary Outcomes (1)

• Change of Morphine Use

  24, 48 and 72 hours post-op

Study Arms (2)

patients receiving dexamethasone

EXPERIMENTAL

subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline

Drug: Dexamethasone

placebo

PLACEBO COMPARATOR

100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section

Other: placebo

Interventions

Dexamethasone DRUG

subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline

patients receiving dexamethasone

placebo OTHER

100mL of normal saline (placebo)

placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women undergoing Cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Audrey Merriam
• Organization: Yale School of Medicine

audrey.merriam@yale.edu

203-785-7813

Study Officials

• Victoria Wesevich, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a pilot double blind, placebo controlled randomized control trial using 40 subjects

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: July 20, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Locations

US (1)