NCT02212210

Maternal Epidural Steroids and Hyperthemia

Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Methylprednisolone
DRUG	Normal saline

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-04-01
• Completion: 2015-10-01
• First posted: 2014-08-08
• Last updated: 2017-08-29

Locations

1 site across 1 country: United States