A Phase 4 interventional study of Dexamethasone and placebo in Post-Cesarean Pain and Cesarean Section Complications, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Yale University · Phase 4, Interventional, and Supportive care
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.
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 to have had an epidural placement. Further, Gabapentin, clonidine and ketamine are associated with CNS effects like sedation or confusion that could make health care providers less likely to be comfortable giving these women additional oxycodone due to possible worsened sedation or respiratory depression. Lastly, the researchers wanted to give a drug that both obstetricians and pediatricians were comfortable with from extensive use in our maternal population. Thus, a single administration IV dexamethasone was chosen for this study. Dexamethasone has been used as an adjunct for post-operative pain management in many types of surgeries. Although no large randomized trials exist, several small trials suggest an analgesic and opioid sparing effect of dexamethasone post-operatively for both pregnant and non-pregnanat patients; however these studies excluded patients on MAT
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
Drug: Dexamethasone
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
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
100mL of normal saline (placebo)
Mean Pain Score
Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
Time frame: 24, 48, 72 and 96 hours post-op
Change of Morphine Use
Comparison of total morphine dose equivalents used by the patient during this period will be examined. The total morphine dose equivalents will be calculated from the total narcotic dose and appropriate conversion (i.e. dilaudid dose to morphine dose equivalents). This will be calculated as a total daily dose for the hospital stay and an average dose/d over the entire hospital stay. These 2 separate calculations will be used because it is presumed that narcotic use will decrease with each day post-op. Calculating an average dose/d over the entire hospital stay will account for women who are discharged on different postoperative days.
Time frame: 24, 48 and 72 hours post-op
| Milestone | Patients Receiving Dexamethasone | Placebo |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
| score on a scale | Patients Receiving Dexamethasone | Placebo |
|---|---|---|
| 0-24 hours post-op | 4.1 ± 2.9 | 4.2 ± 3.2 |
| 25-48 hours post-op | 5.1 ± 2.3 | 5.2 ± 2.0 |
| 49-72 hours post-op | 4.6 ± 2.2 | 4.5 ± 1.9 |
| 73-96 hours post-op | 3.9 ± 2.4 | 3.8 ± 2.0 |
Comparison of total morphine dose equivalents used by the patient during this period will be examined. The total morphine dose equivalents will be calculated from the total narcotic dose and appropriate conversion (i.e. dilaudid dose to morphine dose equivalents). This will be calculated as a total daily dose for the hospital stay and an average dose/d over the entire hospital stay. These 2 separate calculations will be used because it is presumed that narcotic use will decrease with each day post-op. Calculating an average dose/d over the entire hospital stay will account for women who are discharged on different postoperative days.
| Morphine milligram equivalents/day | Patients Receiving Dexamethasone | Placebo |
|---|---|---|
| 0-24 hours post-op | 32.3 ± 30.6 | 34.4 ± 28.9 |
| 25-48 hours post-op | 38.3 ± 29.6 | 44.5 ± 34.2 |
| 49-72 hours post-op | 14.3 ± 22.9 | 20.6 ± 32 |
Collected over up to 96 hours post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Receiving Dexamethasone | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Placebo | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Mean | 31.4 ± 4.1 | 31.7 ± 3.6 | 31.6 ± 3.8 |
| Sex: Female, Male(Participants) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 11 | 11 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Gravidity(pregnancies) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Mean | 3.8 ± 1.1 | 3.8 ± 1.5 | 3.8 ± 1.3 |
| Living Children(children) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Mean | 1.3 ± 0.6 | 1.6 ± 1.1 | 1.4 ± 0.9 |
| Body Mass Index (BMI) at Delivery(kg/m^2) | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Mean | 35.9 ± 8.3 | 30.2 ± 5.2 | 33.1 ± 7.3 |
4 further baseline measures are reported on the registry.
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