Severe Preeclampsia
Conditions
Brief summary
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.
Interventions
BIOLOGICALAMAG-423 (digoxin immune fab)
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
OTHERPlacebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Sponsors
AMAG Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fetal gestational age 23 0/7 to 31 6/7 weeks * Treated with expectant management * Meets modified ACOG criteria for severe preeclampsia * Willing and able to provide written, informed consent
Exclusion criteria
* Decision to deliver within 24 hours has been made * Weight \> 150 kg * Eclampsia * Significant antecedent obstetrical problems * Clinically significant fetal anomaly or chromosomal abnormalities * Chronic renal disease * Active hepatic disease, antiphospholipid antibody syndrome, or lupus * Unstable medical or psychiatric disorder * Need for use of digitalis like products * History of anaphylactic allergic reactions * Prior use of antibodies/fab fragments from sheep * Serum creatinine ≥ 2.0 mg/dL * Platelet count \< 50,000 * Pulmonary edema * Estimated fetal weight \< 5th percentile
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age | 36 weeks corrected gestational age | Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Creatinine | From treatment initiation to 24 hours post first dose | Maternal change from baseline in serum creatinine to 24 hours post first dose |
| Incidence of Pulmonary Edema | From treatment initiation until completion of treatment phase (up to 4 days) | Maternal incidence of pulmonary edema during the treatment period |
Countries
Poland, South Africa, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants |
| Age, Continuous | 29.0 years STANDARD_DEVIATION 6.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fetal Gestational Age at Consent <= 27 weeks 6/7 days | 11 weeks |
| Fetal Gestational Age at Consent > 27 weeks 6/7 days | 36 weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 0 / 28 | 0 / 29 |
| serious Total, serious adverse events | 15 / 28 | 8 / 29 |
Outcome results
None listed