Study Stopped
PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed
Maternal Epidural Steroids and Hyperthemia
Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Feb 2012
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedAugust 29, 2017
August 1, 2014
2.2 years
August 4, 2014
August 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of maternal fever
Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
delivery
Secondary Outcomes (1)
Rate of funisitis
delivery
Other Outcomes (1)
IL-6 level
delivery
Study Arms (2)
Methylprednisolone
ACTIVE COMPARATOR1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline
Normal saline
PLACEBO COMPARATOR2cc preservative free normal saline
Interventions
Eligibility Criteria
You may qualify if:
- Nulliparity
- Age\>=18
- Patient requests epidural analgesia
- GA \>= 37 weeks
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher G Goodier, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 8, 2014
Study Start
February 1, 2012
Primary Completion
April 1, 2014
Study Completion
October 1, 2015
Last Updated
August 29, 2017
Record last verified: 2014-08