Efficacy Study of Digibind for Treatment of Severe Preeclampsia

Inclusion Criteria

• A subject with a diagnosis of severe preeclampsia will be eligible for inclusion if she meets the following criteria:
• In the opinion of the investigator delivery is considered to be probably required within a 72 hour time period and, therefore, corticosteroid administration is needed.
• Meets both American College of Obstetricians (ACOG) criteria for preeclampsia (modified to limit selection to patients with the required severity)
• A systolic blood pressure of 140 mm Hg or higher or a diastolic blood pressure of 90 mm Hg or higher occurring after 20 weeks of gestation in a woman whose blood pressure has previously been normal;
• Proteinuria, with excretion of 0.3 g or more of protein in a 24-hour urine specimen or a urine dipstick reading of 1+ or more.
• Meets at least one of the following ACOG criteria for severe preeclampsia (modified to limit selection to patients with the required severity)

. Proteinuria of 5 grams or higher in a 24-hour specimen or 3+ or greater on 2 random urine samples collected at least 4 hours apart

• A systolic blood pressure of 160 mm Hg or higher or a diastolic blood pressure of 110 mm Hg or higher on two occasions six or more hours apart in a pregnant woman who is on bed rest;
• Oliguria, with excretion of less than 500 ml of urine in 24 hours or average of ≤ 25 ml/hour over a 3 hour period;
• Pulmonary edema;
• Impairment of liver function [AST(SGOT) > 72 U/L or ALT(SGPT) > 72 U/L or LDH > 600 U/L or Total Bilirubin >1.2 mg/DL)];
• Visual or cerebral disturbances;
• Decreased platelet count (≥50, 000/mm3 and ≤ 100,000/mm3).
• Has a fetal gestational age of 23 5/7 to 34 weeks.

Exclusion Criteria

• Is in need of immediate delivery as soon as clinically appropriate
• Eclampsia
• Significant antecedent obstetrical problems which may interfere with study assessments or safe participation in the study
• Evidence of non-reassuring fetal well being
• Evidence of lethal fetal anomaly
• Antecedent hypertension (hypertension secondary to preeclampsia, treated or untreated is allowed)
• Antecedent renal, hepatic, or autoimmune disease
• Medical or psychiatric disorder which is unstable or which might interfere with study assessments or safe participation in the study
• Evidence on medical history/evaluation of use of or need for digitalis-like products currently or in the future
• History of a severe allergic reaction to previous medication, severe asthma, or atopy. (Patients with a history of allergic reactions to antibiotics, papain, chymopapain, or other papaya extracts may be more susceptible to allergic reactions to Digibind®)
• Prior use of antibodies/FAB fragments from sheep (e.g. Digibind®, DigiFab, CroFab)
• Serum creatinine ≥ 1.5 mg/dl
• Platelet count <50,000/mm3
• Patient intends to breast feed and does not agree to wait for a minimum of seven days after the last Digibind® dose (a breast pump would be used for this seven day period)
• Inability to understand and provide informed consent