Complication of Anesthesia During Pregnancy, Unspecified, Fever, Labor Pain
Conditions
Brief summary
The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.
Detailed description
The association between epidural analgesia and increased maternal intrapartum temperature has been well documented in multiple randomized controlled trials. The exact mechanism for this elevation in temperature is unknown; however the most likely cause appears to be non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy. The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1% to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.
Interventions
DRUGMethylprednisolone
DRUGNormal saline
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Nulliparity * Age\>=18 * Patient requests epidural analgesia * GA \>= 37 weeks
Exclusion criteria
* No prenatal care * Temperature \>99.4 at decision for epidural placement * Cervical dilation \>4cm * Diabetes (pre-gestational or gestational) * Autoimmune condition * Pre-eclampsia * Maternal heart disease * Current steroid use * Active infection (bacterial or viral) * Wet Tap (CSF on placement of epidural) * Pre-gestational diabetes * Known systemic infection (bacterial, viral, fungal or tubercular) * Known allergy to steroids * Heart failure * Hypertensive crisis * History of active epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of maternal fever | delivery | Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of funisitis | delivery | Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage. |
Other
| Measure | Time frame | Description |
|---|---|---|
| IL-6 level | delivery | Cord blood will be obtained at delivery and plasma will be assessed for IL-\^ levels by standard ELISA. |
Countries
United States
Outcome results
None listed