Pravastatin for Prevention of Preeclampsia (NCT01717586) | Clinical Trial Compass
CompletedPhase 1
Pravastatin for Prevention of Preeclampsia
United States48 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, un…
What they're measuring
1
Number and type of maternal adverse events
Timeframe: From the date of randomization until the date of delivery, assessed up to 210 days
2
Number and type of fetal/neonatal adverse events
Timeframe: From date of birth up to discharge or 120 days after birth.
3
Pharmacokinetic parameters of pravastatin sodium during pregnancy
Timeframe: Between Pre-dose (0) and 24 hours post dose
Trial details
NCT IDNCT01717586
SponsorThe University of Texas Medical Branch, Galveston