Pre-eclampsia MedDRA version: 20.0 Level: PT Classification code 10036485 Term: Pre-eclampsia System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Product Name: Pravastatin
Pharmaceutical Form: Capsule
INN or Proposed INN: Pravastatin Sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical fo
Sponsors
Fundación para la Formación e Investigación Sanitaria (FFIS)
Eligibility
Sex/Gender
All
Inclusion criteria
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 0
Exclusion criteria
Exclusion criteria: For the screening study: • Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine if the use of Pravastatin starting at 35-36 weeks' gestation in women at increased risk of developing pre-eclampsia (high blood pressure in pregnancy) reduces the incidence and severity of this complication.;Secondary Objective: To examine if the use of Pravastatin reduces the incidence of delivery due to complications from high blood pressure, fetal growth restriction, stillbirth or neonatal complications, rate of neonatal intensive care unit admission, and the incidence of placental abruption (separation). A safety assessment of pravastatin administration during pregnancy will also be undertaken. ;Primary end point(s): Incidence of PE after randomisation;Timepoint(s) of evaluation of this end point: Once delivered, data on pregnancy outcome, including labour onset, gestational age at delivery, mode of delivery, development of hypertension in pregnancy, neonatal birth weight and gender, and other obstetrics complications, will be collected from the hospital maternity records or their general medical practitioners. In addition, the obstetric records of women with pre-existing or pregnancy associated hypertension will be examined to determine if the condition is pre-eclampsia requiring delivery after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine the effect of pravastatin on adverse outcome of pregnancy at any gestation. o PE, with delivery at any gestation o GH, with delivery at any gestation o SGA (37 weeks’ gestation. o PE, with delivery at >37 weeks o GH, with delivery at >37 weeks o SGA (37 weeks o Stillbirth at >37 weeks o Placental abruption (clinically or on placental examination) at >37 weeks o Composite of any of the above • To determine the effect of pravastatin on stillbirth or neonatal death o Neonatal death o Neonatal morbidity o To determine the effect of pravastatin on neonatal morbidity Intraventricular haemorrhage,neonatal sepsis, neonatal anaemia, respiratory distress syndrome, necrotising enterocolitis o Composite of any of the above • To determine the effect of pravastatin on neonatal therapy o Neonatal intensive care unit admission o Ventilation - Defined as need of positive pressure (continuous positive airway pressure (CPAP) or nasal continuous positive airway pressure (NCPAP)) or intubation o Composite of any of the above • To determine the effect of pravastatin on the incidence of low birthweight below the 3rd, 5th and 10th centile. o Birthweight will be recorded in the participants’ medical notes and birthweight percentile for gestational age at delivery is calculated using a normal range derived from our population. • To determine the effect of pravastatin on sFLT-1 and PLGF value 1 and 3 weeks after the onset of treatment • Pravastatin safety assessment during pregnancy ;Timepoint(s) of evaluation of this end point: Once delivered, data on pregnancy outcome, including labour onset, gestational age at delivery, mode of delivery, development of hypertension in pregnancy, neonatal birth weight and gender, and other obstetrics complications, will be collected from the hospital maternity records or their general medical practitioners. Neonatal outcomes will be collected from Special Care Baby Unit. | — |
Countries
Belgium, Italy, Spain, United Kingdom
Contacts
Public ContactKypros Niclaides
The Fetal Medicine Foundation
Outcome results
None listed