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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving dexamethasone | Experimental | subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women undergoing Cesarean section
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Wesevich, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving Dexamethasone | subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline |
| FG001 | Placebo | 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 placebo: 100mL of normal saline (placebo) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving Dexamethasone | subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Pain Score | Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest). | Posted | Mean | Standard Deviation | score on a scale | 24, 48, 72 and 96 hours post-op |
|
up to 96 hours post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving Dexamethasone | subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Audrey Merriam | Yale School of Medicine | 203-785-7813 | audrey.merriam@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2022 | Mar 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2023 | Mar 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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a pilot double blind, placebo controlled randomized control trial using 40 subjects
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double blind
| placebo | Other | 100mL of normal saline (placebo) |
|
| 24, 48 and 72 hours post-op |
| Placebo |
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 placebo: 100mL of normal saline (placebo) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gravidity | Mean | Standard Deviation | pregnancies |
|
| Living Children | Mean | Standard Deviation | children |
|
| Body Mass Index (BMI) at Delivery | Mean | Standard Deviation | kg/m^2 |
|
| Number of Prior Cesarean Sections | Mean | Standard Deviation | Cesarean Sections |
|
| Insurance Type | Count of Participants | Participants |
|
| Medication Type | Count of Participants | Participants |
|
| Breastfeeding | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Morphine milligram equivalents/day | 24, 48 and 72 hours post-op |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | 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 placebo: 100mL of normal saline (placebo) | 0 | 12 | 0 | 12 | 0 | 12 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 49-72 hours post-op |
|