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Maternal Epidural Steroids and Hyperthemia

Primary Purpose

Fever, Labor Pain, Complication of Anesthesia During Pregnancy, Unspecified

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone
Normal saline
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fever

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisolone

Normal saline

Arm Description

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

2cc preservative free normal saline

Outcomes

Primary Outcome Measures

Rate of maternal fever
Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.

Secondary Outcome Measures

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.

Full Information

First Posted
August 4, 2014
Last Updated
August 28, 2017
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02212210
Brief Title
Maternal Epidural Steroids and Hyperthemia
Official Title
Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Labor Pain, Complication of Anesthesia During Pregnancy, Unspecified

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
2cc preservative free normal saline
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
DEPO-MEDROL
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Saline placebo
Primary Outcome Measure Information:
Title
Rate of maternal fever
Description
Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
Time Frame
delivery
Secondary Outcome Measure Information:
Title
Rate of funisitis
Description
Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage.
Time Frame
delivery
Other Pre-specified Outcome Measures:
Title
IL-6 level
Description
Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA.
Time Frame
delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G Goodier, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Maternal Epidural Steroids and Hyperthemia

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