Maternal Epidural Steroids and Hyperthemia

Early Phase 1

Terminated

• Conditions: Complication of Anesthesia During Pregnancy, Unspecified; Fever; Labor Pain
• Interventions: Drug: Normal saline; Drug: Methylprednisolone

• Registration Number: NCT02212210
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-04
• Status Verified: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Study Completion: 2015-10
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	2cc preservative free normal saline
Methylprednisolone	Methylprednisolone	1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline

Primary Outcome Measures

Name	Time	Method
Rate of maternal fever	delivery	Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.

Secondary Outcome Measures

Name	Time	Method
Rate of funisitis	delivery	Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States