Randomized, Double-Blind, Placebo-Controlled Study of Effects of Combined Spinal Epidural Analgesia on Intrapartum Fever.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Ochsner Health System
- Locations
- 1
- Primary Endpoint
- temperature of mother
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 34 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
- •admit temperature > 99.5
- •active drug/alcohol dependence
- •active genital herpes infection
- •allergy to anesthetics used
Arms & Interventions
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.
Intervention: saline (Drug)
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.
Intervention: fentanyl/bupivacaine/epinephrine (Drug)
Outcomes
Primary Outcomes
temperature of mother
Time Frame: time of delivery
Secondary Outcomes
- neonatal APGAR, temperature and cord blood gas(time of birth)