Prevention of pre­eclampsia (high blood pressure): Randomised trial of Pravastatin versus placebo

Phase 1

• Conditions: Pre-eclampsia; MedDRA version: 20.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-005206-19-IT
• Lead Sponsor: Fundación para la Formación e Investigación Sanitaria (FFIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-12
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1120

Inclusion Criteria

For the screening study:
• Singleton pregnancy;
• Live fetus at 35+0-36+6 weeks’ gestation;
• Informed and written consent.

For the randomised trial:
• Same as for screening
• High-risk for term-PE at screening by the algorithm combining maternal history and characteristics, MAP, PLGF and sFLT-1;
• Informed and written consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For the screening study:
• Age <18 years;
• Multiple pregnancy;
• Unconscious or very ill;
• Serious mental illness;
• Learning difficulties;
• Not fluent in local language and absence of interpreter.

For the randomised trial:
• Same as for screening, but in addition:
• Major fetal abnormality;
• Women with established PE;
• Statin use within 28 days prior to randomisation;
• Women with contraindications for statin therapy:
-Hypersensitivity to pravastatin or any component of the product;
-Lactose intolerance
-Current or previous cancer
-Previous solid organ transplant
-Active liver disease (acute hepatitis, chronic active hepatitis) in the past 6 months
-Chronic renal disease/insufficiency with baseline serum creatinine >1.5mg/dL
-History of myopathy or rhabdomyolysis;
-ALT and/or AST levels = 2 x the upper limit of normal
-Creatine kinase levels = 5 x the upper limit of normal
-Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins, such as immunosuppressive drugs, fibrates, gemfibrozil, niacin, protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitor), erythromycin, clarithromycin, itraconazole, cholestyramine, digoxin, rifampicin (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified