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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 2000

Inclusion Criteria

- ? Age > 18 years;
- ? Singleton pregnancies;
- ? Live fetus at 11-13 weeks of gestation;
- ? High-risk for preterm-PE at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (placental growth factor);
?- Be fluent in the local language (otherwise interpreters will be used)
- ? 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 2000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-? Statin use in current pregnancy (administration must have ceased >28 days prior to randomisation);
-? Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks’ assessment;
-? Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness;
-? Women with contraindications for statin therapy:
a.? Hypersensitivity to Pravastatin or any component of the product;
b. Active liver disease in the past 6 months (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (= 2 x the upper limit of normal values for serum transaminases [ALT and/or AST], confirmed either by available blood results within the recruiting hospital within the last 6 months or blood taken prior to randomisation));
c.? History of myopathy or rhabdomyolysis;
- ? Creatine kinase = 5 x the upper limit of normal
-? Women with any of the following conditions:
a. ? Status post solid organ transplant;
b.? Chronic renal disease/insufficiency with baseline serum creatinine >1.5mg/dL;
c.? Cancer;
-? Autoimmune diseases which may induce preeclampsia
-? Lactose intolerance
-? 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;
-? Plans to deliver in a non-network site,
-? Any other reason the clinical investigators think will prevent the potential

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method