The Effects of Combined Spinal Epidurals on Fever During Labor of First-Time Mothers (CSE)

April 10, 2023 updated by: Ochsner Health System

Randomized, Double-Blind, Placebo-Controlled Study of Effects of Combined Spinal Epidural Analgesia on Intrapartum Fever.

The purpose of this study is to determine if the epidural of local anesthetics has an effect on fever that may occur in first time mothers during labor.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Intrapartum fever (fever during labor) is a real and potentially devastating problem. Infants delivered at term who have been exposed to the mother having a fever during labor have a >9 fold increased risk of cerebral palsy. Studies have also shown an increased risk of neonatal encephalopathy associated with fever during labor. Maternal fever in the absence of infection is associated with a 4 fold increased risk of neonatal hypoxic encephalopathy and 3.4 fold increased risk of unexplained neonatal seizures.

The likely role of inflammatory mediators in the process of maternal fever (temperature >100.4), regardless of etiology, makes it important to further investigational studies in an effort to discover the etiology of intrapartum fever associated with epidural analgesia. If an inflammatory trigger (i.e., the injection of epidural local anesthetics) can be identified or delayed, then the risks of maternal hyperthermia can be minimized and/ or eliminated.

The greatest risk of fever with epidural labor analgesia is seen in women having their first child. This is the same population associated with prolonged labor. Although intrapartum fever has a very low incidence overall, 11-33% of first-time mothers will eventually develop fever >100.4 during epidural analgesia. Although the degree of rise in temperature occurs very slowly, it has been shown to be significant enough to cause increased neonatal sepsis workup and antibiotic coverage for both the mother and the neonate.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • having first child (nulliparous)
  • term pregnancy (> 37 weeks)
  • vertex presentation
  • singleton gestation
  • ability to provide informed consent
  • request for analgesia for labor pain

Exclusion Criteria:

  • birth of second or more child (multiparous)
  • preterm pregnancy (< 37 weeks)
  • presentation other than vertex (ie. breech, transverse)
  • diabetic
  • admit temperature > 99.5
  • active drug/alcohol dependence
  • active genital herpes infection
  • allergy to anesthetics used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
When it is time for the epidural catheter, the mother will receive 2.5 mcg fentanyl spinally and then a bag of preservative-free normal saline will be administered through the epidural pump. When additional pain medication is requested, the mother will receive a known combined spinal epidural solution.
Drug: saline
intrathecal preservative free normal saline, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested
Other Names:
  • placebo
Active Comparator: 2
When it is time for the epidural catheter, the mother will receive 2.5 mcg fentanyl spinally and then a bag of combined spinal epidural anesthetic through the epidural pump. When additional pain medication is requested, the mother will receive a known combined spinal epidural solution.
Drug: fentanyl/bupivacaine/epinephrine
intrathecal 0.125% fentanyl/bupivacaine/epinephrine, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested The mother will then receive a new bag of fentanyl/bupivacaine/epinephrine.
Other Names:
  • combined spinal epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
temperature of mother
Time Frame: time of delivery
time of delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
neonatal APGAR, temperature and cord blood gas
Time Frame: time of birth
time of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: Melissa Russo, M.D., Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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