Maternal Epidural Steroids and Hyperthemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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

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Fever Labor Pain Complication of Anesthesia During Pregnancy, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Methylprednisolone

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

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Normal saline

2cc preservative free normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Interventions

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Methylprednisolone

Intervention Type DRUG

Normal saline

Intervention Type DRUG

Other Intervention Names

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DEPO-MEDROL Saline placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No