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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00802646
First Posted: December 5, 2008
Last Update Posted: July 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ochsner Health System
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • neonatal APGAR, temperature and cord blood gas [ Time Frame: time of birth ]

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

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
First Submitted: December 4, 2008
First Posted: December 5, 2008
Last Update Posted: July 3, 2009
Last Verified: July 2009

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

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