Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation

Medical University of South Carolina1 site in 1 country135 target enrollmentFebruary 2012

ConditionsFever Labor Pain Complication of Anesthesia During Pregnancy, Unspecified

InterventionsMethylprednisolone Normal saline

DrugsMethylprednisolone Normal saline

Overview

Phase: Early Phase 1
Intervention: Methylprednisolone
Conditions: Fever
Sponsor: Medical University of South Carolina
Enrollment: 135
Locations: 1
Primary Endpoint: Rate of maternal fever
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

October 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel