Maternal Epidural Steroids and Hyperthemia

Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation

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.

Study Overview

• Status: Terminated
• Conditions: Fever; Labor Pain; Complication of Anesthesia During Pregnancy, Unspecified
• Intervention / Treatment: Drug: Methylprednisolone; Drug: Normal saline

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Christopher G Goodier, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Goodier_Epidural_Steroids