Maternal Epidural Steroids and Hyperthemia
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|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
|Condition or disease||Intervention/treatment||Phase|
|Fever Labor Pain Complication of Anesthesia During Pregnancy, Unspecified||Drug: Methylprednisolone Drug: Normal saline||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Methylprednisolone
1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline
Other Name: DEPO-MEDROL
Placebo Comparator: Normal saline
2cc preservative free normal saline
Drug: Normal saline
Other Name: Saline placebo
- Rate of maternal fever [ Time Frame: delivery ]Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
- 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.
- IL-6 level [ Time Frame: delivery ]Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA.
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
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Christopher G Goodier, MD||Medical University of South Carolina|