An Early Phase 1 interventional study of Methylprednisolone and Normal saline in Fever, Labor Pain and Complication of Anesthesia During Pregnancy, Unspecified, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Medical University of South Carolina · Early Phase 1, Interventional, and Treatment
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.
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 135 is above the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline
Drug: Methylprednisolone
2cc preservative free normal saline
Drug: Normal saline
Also known as: DEPO-MEDROL
Also known as: Saline placebo
Rate of maternal fever
Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
Time frame: delivery
Rate of funisitis
Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage.
Time frame: delivery
IL-6 level
Cord blood will be obtained at delivery and plasma will be assessed for IL-\^ levels by standard ELISA.
Time frame: delivery
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina