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PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed
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The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.
The association between epidural analgesia and increased maternal intrapartum temperature has been well documented in multiple randomized controlled trials. The exact mechanism for this elevation in temperature is unknown; however the most likely cause appears to be non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy. The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1% to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | 1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline |
|
| Normal saline | Placebo Comparator | 2cc preservative free normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug |
|
| |
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of maternal fever | Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery. | delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of funisitis | Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage. | delivery |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 level | Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA. | delivery |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher G Goodier, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D005334 | Fever |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Drug |
|
|
| D009461 | Neurologic Manifestations |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |