Phase
Condition
High Blood Pressure (Hypertension - Pediatric)
Pregnancy Complications
Preeclampsia
Treatment
Pravastatin
Placebo
Clinical Study ID
Ages > 16 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
16 years or older at time of consent with ability to give informed consent
Single or twin gestation with cardiac activity in one or both fetuses. Higher ordermultifetal gestations reduced to twins, either spontaneously or therapeutically, arenot eligible unless the reduction occurred by 13 weeks 6 days project gestationalage.
Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days basedon clinical information and evaluation of the earliest ultrasound.
Documented history (by chart or delivery/operative note review) of priorpreeclampsia with delivery less than or equal to 34 weeks 0 days gestation in anyprevious pregnancy. If in the index pregnancy, the woman was induced by 34 weeks 0days gestation and delivered within 48 hours in the same hospitalization, that womanwould be eligible.
Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.
Exclusion
Exclusion Criteria:
Monoamniotic gestation because of the risk of fetal demise
Known chromosomal, genetic or major malformations
Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6days gestation, from triplets to twins or twins to singleton is not an exclusion.
Contraindications for statin therapy:
Hypersensitivity to pravastatin or any component of the product
Active liver disease: acute hepatitis or chronic active hepatitis
Statin use in current pregnancy
Patients with any of the following medical conditions:
Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because ofincreased risk of myopathy
HIV positive, because of increased risk of myopathy with use of proteaseinhibitors
Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because ofassociation with adverse pregnancy outcomes
Current use of concomitant medication with potential for drug interaction withstatins (i.e.,, cyclosporine, fibrates, niacin, erythromycin). Patients will not beexcluded if the drug is discontinued (at least one week) prior to randomization.
Participating in another intervention study that influences the primary outcome inthis study
Plan to deliver in a non-network site
Participation in this trial in a previous pregnancy. Patients who were screened in aprevious pregnancy, but not randomized, do not have to be excluded.
Study Design
Study Description
Connect with a study center
University of Alabama - Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Case Western Reserve-Metro Health
Cleveland, Ohio 44109
United StatesSite Not Available
Ohio State University Hospital
Columbus, Ohio 43210
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Brown University
Providence, Rhode Island 02905
United StatesSite Not Available
University of Texas Medical Branch
Galveston, Texas 77555
United StatesSite Not Available
University of Texas - Houston
Houston, Texas 77030
United StatesSite Not Available
University of Utah Medical Center
Salt Lake City, Utah 84132
United StatesSite Not Available
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