Efficacy Study of Digibind for Treatment of Severe Preeclampsia
Completed · Phase 2 · Has a placebo group
Conditions studied: Pre-eclampsia
In brief
The purpose of this study is to determine whether a commercially available anti-digoxin antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this would allow more time for maternally administered steroids to prevent the development of respiratory complications in premature infants.
Key facts
- Study ID
- NCT00158743
- Run by
- BTG International Inc.
- People needed
- 51
- Starts
- 2004-02-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2014-08-08
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of South Alabama — Mobile, Alabama, United States
- Phoenix Perinatal Associates — Phoenix, Arizona, United States
- Winnie Palmer Hospital — Orlando, Florida, United States
- Department of Obstetrics and Gynecology, Louisiana State University Health Sciences Center, PO Box 33932, 1501 Kings Highway — Shreveport, Louisiana, United States
- St Mary's Health Center — St Louis, Missouri, United States
- Medical University of South Carolina, 96 Jonathan Lucas Street, Suite 634, PO Box 250619 — Charleston, South Carolina, United States
- Department of OB-GYN, Division of Maternal Fetal Medicine, University of Texas Medical Branch, 301 University Boulevard — Galveston, Texas, United States
- St Mark's Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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