Pravastatin for Prevention of Preeclampsia

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Northwestern University; University of Pittsburgh; University of Texas
• Treatments: Pravastatin

Criteria

Inclusion Criteria:

Documented history (review of chart or delivery note) of prior severe early onset PE in a prior pregnancy and requiring delivery ≤340/7 weeks' gestation. If in the index pregnancy, the woman was induced at the upper limit of 34 0/7 weeks of pregnancy and delivered within 48 hours in the same hospitalization, that woman could be enrolled. Women with severe PE in a pregnancy remote (greater than 2 pregnancies removed) from the current pregnancy do not qualify.

• 18 years or older with the ability to give informed consent

• Singleton pregnancy

• Normal serum transaminase (ALT and AST) concentrations in the last 6-months

• Gestational age (GA) between 12 weeks 0 days to 16 weeks 6 days based on clinical information and confirmed by an ultrasound per study procedures.

• Willingness to participate in planned PK study visits

Exclusion Criteria:

Known chromosomal, genetic, or major fetal malformations, fetal demise, or planned termination

• Patients with contraindications for statin therapy:

• Hypersensitivity to pravastatin or any component of the product

• Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (2 x normal of serum transaminases)

• History of myopathy or rhabdomyolysis

• Patients with any of the following conditions:

• HIV positive

• Status post solid organ transplant

• Chronic renal disease/insufficiency with baseline serum creatinine ≥1.5 mg/dL

• Uterine malformations (didelphus, bicornuate, unicornate)

• Cancer

• Statin use in current pregnancy

• Current use of medications with potential drug interactions with statins, such as cyclosporine, fibrates, gemfibrozil, niacin, erythromycin, fluconazole, itraconazole, cholestyramine, digoxin, rifampin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time)

• Participating in another intervention study that influences the outcomes of this study

• Plans to deliver in a non-network site