Clinical trial NCT00802646: The Effects of Combined Spinal Epidurals on Fever During Labor of First-Time Mothers
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Effects of Combined Spinal Epidural Analgesia on Intrapartum Fever.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vaginal Delivery
Keywords: first-time mother
epidural request
vaginal childbirth
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: temperature of mother
timeFrame: time of delivery
Secondary outcomes:
measure: neonatal APGAR, temperature and cord blood gas
timeFrame: time of birth
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Melissa Russo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lieberman E, Lang JM, Frigoletto F Jr, Richardson DK, Ringer SA, Cohen A. Epidural analgesia, intrapartum fever, and neonatal sepsis evaluation. Pediatrics. 1997 Mar;99(3):415-9. doi: 10.1542/peds.99.3.415.
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