This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
University of South Alabama
Mobile, Alabama, United States
University of Kansas Medical Center
Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Time frame: 36 weeks corrected gestational age
Change From Baseline in Serum Creatinine
Maternal change from baseline in serum creatinine to 24 hours post first dose
Time frame: From treatment initiation to 24 hours post first dose
Incidence of Pulmonary Edema
Maternal incidence of pulmonary edema during the treatment period
Time frame: From treatment initiation until completion of treatment phase (up to 4 days)
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Kansas City, Kansas, United States
Children's Hospital Foundation Building
Louisville, Kentucky, United States
Louisiana State University Health Sciences Center in New Orleans
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Detroit Medical Center (DMC)
Detroit, Michigan, United States
University Of Mississippi Medical Center
Jackson, Mississippi, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospitals Case Medical Center-Case Western Reserve University (CWRU)
Cleveland, Ohio, United States
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States
...and 8 more locations