Pravastatin for Prevention of Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2024-02-12

Brief Summary

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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.

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Detailed Description

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Preeclampsia shares pathogenic similarities with adult cardiovascular diseases as well as many risk factors. Endothelial dysfunction and inflammation are fundamental for the initiation and progression of both. There is strong evidence that 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) are beneficial in primary and secondary prevention of cardiovascular mortality and other cardiovascular events. Biological plausibility as well as animal data supports a similar role for statins in preeclampsia.

Currently, there are no clinically available agents to prevent preeclampsia. However because of the below properties of statins, this class of medications could substantially contribute to preeclampsia prevention.

1. Statins pleiotropic actions on various mechanisms: reversing the angiogenic imbalance by upregulating vascular endothelial growth factor (VEGF) and placental growth factor (PlGF), and reducing the antiangiogenic factors such as soluble fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng).
2. Statins up regulation of endothelial nitric oxide synthase, leading to improved nitric oxide production in the vasculature and to activate the heme oxygenase-1/carbon monoxide (HO-1/CO) pathway, protecting the endothelium and reducing the inflammatory and oxidative insults.

The purpose of this pilot study is to evaluate the maternal-fetal safety and pharmacokinetic (PK) profiles of pravastatin when used in pregnant women at high-risk of developing preeclampsia.

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pravastatin Group

Pregnant women at high-risk for preeclampsia who are taking pravastatin during their pregnancy.

Group Type ACTIVE_COMPARATOR

Pravastatin

Intervention Type DRUG

Comparison of different drug dosages. Women will be instructed to take a pravastatin pill everyday starting the day of randomization and ending the day of delivery. The women will be divided into three cohorts. Each cohort will receive one of the following doses of pills: 10mg or 20mg or 40mg.

Control Group

Pregnant women who are at high-risk for developing preeclampsia who are taking a placebo during their pregnancy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Women will be instructed to take a placebo pill daily beginning the day of randomization and ending the day of delivery.

Interventions

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Pravastatin

Comparison of different drug dosages. Women will be instructed to take a pravastatin pill everyday starting the day of randomization and ending the day of delivery. The women will be divided into three cohorts. Each cohort will receive one of the following doses of pills: 10mg or 20mg or 40mg.

Intervention Type DRUG

Placebo

Women will be instructed to take a placebo pill daily beginning the day of randomization and ending the day of delivery.

Intervention Type DRUG

Other Intervention Names

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pravastatin sodium Brand name: Pravachol®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No