Pravastatin to Prevent Preeclampsia

Last updated: July 8, 2024
Sponsor: The George Washington University Biostatistics Center
Overall Status: Terminated

Phase

3

Condition

High Blood Pressure (Hypertension - Pediatric)

Pregnancy Complications

Preeclampsia

Treatment

Pravastatin

Placebo

Clinical Study ID

NCT03944512
HD036801-Pravastatin
5U10HD036801-20
  • Ages > 16
  • Female

Study Summary

This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 16 years or older at time of consent with ability to give informed consent

  2. 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.

  3. Gestational age at randomization between 12 weeks 0 days and 16 weeks 6 days basedon clinical information and evaluation of the earliest ultrasound.

  4. 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.

  5. Normal serum transaminase (AST/ALT) concentrations documented in the last 6 months.

Exclusion

Exclusion Criteria:

  1. Monoamniotic gestation because of the risk of fetal demise

  2. Known chromosomal, genetic or major malformations

  3. 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.

  4. Contraindications for statin therapy:

  5. Hypersensitivity to pravastatin or any component of the product

  6. Active liver disease: acute hepatitis or chronic active hepatitis

  7. Statin use in current pregnancy

  8. Patients with any of the following medical conditions:

  9. Uncontrolled hypothyroidism with a TSH level above 10 mIU/L, because ofincreased risk of myopathy

  10. HIV positive, because of increased risk of myopathy with use of proteaseinhibitors

  11. Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL, because ofassociation with adverse pregnancy outcomes

  12. 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.

  13. Participating in another intervention study that influences the primary outcome inthis study

  14. Plan to deliver in a non-network site

  15. 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

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Pravastatin
Phase: 3
Study Start date:
July 17, 2019
Estimated Completion Date:
June 20, 2024

Study Description

Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major cause of maternal and neonatal morbidities and mortality. Women who experience preeclampsia in one pregnancy are at higher risk of developing preeclampsia in a subsequent pregnancy than those who have never experienced the condition. There is evidence from laboratory studies and clinical trials, as well as biological plausibility, to suggest that statins may prevent the development of preeclampsia by reversing various pathways associated with preeclampsia. Pravastatin has a favorable safety profile and pharmacokinetic properties.

The study is a randomized placebo-controlled multi-center clinical trial of 1,550 women with a prior history of preeclampsia that required delivery at less than 34 weeks, randomized to either 20mg pravastatin or an identical appearing placebo daily until delivery. Women with a singleton or twin gestation will be randomized between 12 weeks 0 days and 16 weeks 6 days will be followed monthly during pregnancy and then at 6 weeks postpartum. Children will have follow-up visits at 2 and 5 years of age to assess growth, cognition, behavior, motor skills, vision and hearing.

Connect with a study center

  • University of Alabama - Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Case Western Reserve-Metro Health

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Brown University

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • University of Texas - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah Medical Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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