NCT00802646

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Delivery

Interventions

Type	Name	Description
DRUG	saline	intrathecal preservative free normal saline, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-12-05
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States