Maternal Epidural Steroids and Hyperthemia

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Early Phase 1

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

Treatments: Drug: Methylprednisolone; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02212210

Goodier_Epidural_Steroids

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline

Treatment:

Drug: Methylprednisolone

Normal saline

Placebo Comparator group

Description:

2cc preservative free normal saline

Treatment:

Drug: Normal saline