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Maternal Epidural Steroids and Hyperthemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212210
Recruitment Status : Terminated (PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed)
First Posted : August 8, 2014
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher G. Goodier, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Fever Labor Pain Complication of Anesthesia During Pregnancy, Unspecified Drug: Methylprednisolone Drug: Normal saline Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation
Study Start Date : February 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: Methylprednisolone
1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline
Drug: Methylprednisolone
Other Name: DEPO-MEDROL

Placebo Comparator: Normal saline
2cc preservative free normal saline
Drug: Normal saline
Other Name: Saline placebo




Primary Outcome Measures :
  1. Rate of maternal fever [ Time Frame: delivery ]
    Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.


Secondary Outcome Measures :
  1. Rate of funisitis [ Time Frame: 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 Outcome Measures:
  1. IL-6 level [ Time Frame: delivery ]
    Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212210


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Christopher G Goodier, MD Medical University of South Carolina

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Responsible Party: Christopher G. Goodier, Instructor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02212210    
Other Study ID Numbers: Goodier_Epidural_Steroids
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2014
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents