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

This study has been withdrawn prior to enrollment.
(study moved to alternate site)
Sponsor:
Information provided by:
Ochsner Health System
ClinicalTrials.gov Identifier:
NCT00802646
First received: December 4, 2008
Last updated: July 2, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Vaginal Delivery
Drug: saline
Drug: fentanyl/bupivacaine/epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Placebo-Controlled Study of Effects of Combined Spinal Epidural Analgesia on Intrapartum Fever.

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • temperature of mother [ Time Frame: time of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neonatal APGAR, temperature and cord blood gas [ Time Frame: time of birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: combined spinal epidural

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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802646

Locations
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Investigators
Principal Investigator: Melissa Russo, M.D. Ochsner Health System
  More Information

Publications:

Responsible Party: Melissa Russo, M.D., Ochsner Health System
ClinicalTrials.gov Identifier: NCT00802646     History of Changes
Other Study ID Numbers: 2008., 2008.
Study First Received: December 4, 2008
Last Updated: July 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
first-time mother
epidural request
vaginal childbirth

Additional relevant MeSH terms:
Analgesics
Bupivacaine
Epinephrine
Fentanyl
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Mydriatics
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on November 27, 2014