Maternal Epidural Steroids and Hyperthemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation

Conditions
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Fever, Labor Pain, Complication of Anesthesia During Pregnancy, Unspecified

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Nulliparity Age>=18 Patient requests epidural analgesia GA >= 37 weeks Exclusion criteria: No prenatal care Temperature >99.4 at decision for epidural placement Cervical dilation >4cm Diabetes (pre-gestational or gestational) Autoimmune condition Pre-eclampsia Maternal heart disease Current steroid use Active infection (bacterial or viral) Wet Tap (CSF on placement of epidural) Pre-gestational diabetes Known systemic infection (bacterial, viral, fungal or tubercular) Known allergy to steroids Heart failure Hypertensive crisis History of active epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline | Drug: Methylprednisolone<br> <br> * Other names: DEPO-MEDROL;|
| Placebo Comparator: Normal saline<br>2cc preservative free normal saline | Drug: Normal saline<br> <br> * Other names: Saline placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |