Maternal Epidural Steroids and Hyperthemia

Labor Pain Clinical Trial

Official title:

Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02212210
• Other study ID #: Goodier_Epidural_Steroids
• Status: Terminated
• Phase: Early Phase 1
• First received: August 4, 2014
• Last updated: August 28, 2017
• Start date: February 2012
• Est. completion date: October 2015

Study information

• Verified date: August 2014
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: October 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Anesthesia During Pregnancy, Unspecified
• Fever
• Labor Pain

Intervention

Drug:
• Methylprednisolone

• Normal saline

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IL-6 level	Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA.	delivery
Primary	Rate of maternal fever	Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.	delivery
Secondary	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.	delivery