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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Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00802646
Acronym
CSE
Enrollment
0
Registered
2008-12-05
Start date
2009-06-30
Completion date
2010-06-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Delivery

Keywords

first-time mother, epidural request, vaginal childbirth

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.

Interventions

DRUGsaline

intrathecal preservative free normal saline, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested

DRUGfentanyl/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.

Sponsors

Ochsner Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 34 Years
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) * diabetic * admit temperature \> 99.5 * active drug/alcohol dependence * active genital herpes infection * allergy to anesthetics used

Design outcomes

Primary

MeasureTime frame
temperature of mothertime of delivery

Secondary

MeasureTime frame
neonatal APGAR, temperature and cord blood gastime of birth

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026