Status:
TERMINATED
Maternal Epidural Steroids and Hyperthemia
Lead Sponsor:
Medical University of South Carolina
Conditions:
Fever
Labor Pain
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT02212210
Start Date
February 1 2012
End Date
October 1 2015
Last Update
August 29 2017
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425