Pre-eclampsia Pregnancy and Childbirth
Conditions
Interventions
All women attending for the routine risk assessment for Down's syndrome at 11-13 weeks will be screened for pre-eclampsia. Women will then be classified as high and low risk for pre-eclampsia based
Sponsors
Health Foundation for Education and Research in the Region of Murcia (Fundación para la Formación e Investigación Sanitaria)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Singleton pregnancies 3. Live fetus at 11-13 weeks' of gestation 4. 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) 5. English or Spanish speaking (otherwise interpreters will be used) 6. Informed and written consent
Exclusion criteria
Exclusion criteria: 1. Statin use in current pregnancy (administration must have ceased >28 days prior to randomisation) 2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment 3. Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness 4. Women with contraindications for statin therapy 5. Hypersensitivity to Pravastatin or any component of the product 6. Active liver disease in the past 6 months (acute hepatitis, chronic active hepatitis) by medical history 7. Unexplained elevations (1.5x normal) of serum transaminases (ALT and AST), confirmed either by available blood results within the recruiting hospital in the last 6 months or blood taken prior to randomisation or jaundice 8. Women with any of the following conditions as it may predispose them to adverse events or side effects 9. Current (last 28 days) heavy alcohol use defined as =2 drinks per day 10. Illicit drug use 11. Amyotrophic lateral sclerosis (ALS) 12. Concomitant therapy with amiodarone, azole antifungals, diltiazem, gemfibrozil, nefazodone, nicotinic acid, protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitior), verapamil, fibrates, niacin (vitamin B3), cyclosporin, clarithromycin or erythromycin or other macrolide antibiotics 13. History of cholestasis of the liver in prior pregnancy 14. Personal or family history of myopathy or rhabdomyolysis 15. Women with any of the following medical conditions as described in medical record or patient history 16. Pregestational diabetes mellitus 17. Status post solid organ transplant 18. Chronic renal disease/insufficiency with baseline serum creatinine =1.5 mg/dL 19. Epilepsy or other seizure disorder 20. Uterine malformations 21. Cancer 22. Heart disease including prior myocardial infarction and prior cerebrovascular accident. 23. Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins such as immunosuppressive drugs, gemfibrozil, niacin, erythromycin, itraconazole, cholestyramine, digoxin, rifampicin (Patients will not be excluded if the drug has been discontinued) 24. Inability to tolerate oral medications secondary to severe nausea and vomiting of pregnancy 25. Participating in another intervention study that influences maternal and fetal morbidity and mortality 26. Plans to deliver in a non-network site 27. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of preterm pre-eclampsia (PE) < 37 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of early-PE (<34 weeks) and total PE (at any gestation) 2. Neonatal birthweight below the 3rd, 5th and 10th centile 3. Stillbirth or neonatal death due to any cause 4. Stillbirth or neonatal death ascribed to PE or fetal growth restriction 5. Stillbirth or neonatal death in association with maternal or neonatal bleeding 6. Rate of neonatal intensive care unit admission 7. Composite measure of neonatal mortality and morbidity 8. Placental abruption (clinically or on placental examination) 9. Spontaneous preterm delivery <34 weeks and <37 weeks | — |
Countries
Spain, United Kingdom
Outcome results
None listed