NCT03648970

Indonesia Pravastatin to Prevent Preeclampsia Study

Pravastatin to Prevent Preeclampsia and Reduce Maternal-Neonatal Mortality and Morbidity in High Risk Preeclampsia Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Universitas Airlangga · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

Summary

BACKGROUND Preeclampsia is a major cause of maternal and neonatal morbidity worldwide. There is currently no cure for preeclampsia, the only definitive treatment is termination of pregnancy by induction of labour or caesarean section. Statin has been proposed to represent a new approach to improve disease outcome/prevent preeclampsia based on its multilayered activity toward pregnancy protection, including: protection of vascular endothelial cells survival, induce expression of heme oxygenase 1 (HO-1), inhibiting the release of soluble FMS-like tirosine kinase-1 (sFlt-1) and soluble endoglin (sEng), two main culprits in the pathophysiology of preeclampsia. OBJECTIVE The aim of this study is to observe the effect of pravastatin administration in patients with high risk of preeclampsia in order to reduce maternal and neonatal mortality and morbidity. METHODS This is a prospective randomized controlled clinical trial. The research will be held in 5 maternal fetal medicine centers in Indonesia (multicenter study). The recruitment will be done by permuted block random sampling methods, with sample size around 280 patients divides into two group. Patients with high risk of preeclampsia will be randomized either to get pravastatin 2 x 20 mg per oral and aspirin 1 x 80 mg (treatment group) or low dose aspirin only (control group). The patient will be followed regularly until delivery to obtain detailed maternal and neonatal outcome. OUTCOME Primary Outcomes: Maternal preeclampsia, severe preeclampsia, gestational hypertension, indicated preterm delivery less than 37 weeks, indicated preterm delivery less than 34 weeks, maternal complications, length of hospital stay, and any serious adverse event. Secondary Outcomes: Composite fetal/neonatal mortality and morbidity (stillbirth, neonatal death, respiratory distress syndrome, intracerebral hemorrhage, neonatal sepsis, intra uterine growth restriction \[Small for Gestational Age (SGA) \< 5th centile\], and necrotizing enterocolitis), birthweight, birthweight percentile, level of care (well baby, intermediate, NICU), NICU length of stay, ventilator usage, and length of perinatal hospital stay. KEYWORDS: pravastatin, preeclampsia, neonatal mortality, neonatal morbidity

Conditions

• Pre-Eclampsia

Interventions

Type	Name	Description
DRUG	Pravastatin	The participant will be given pravastatin 2 x 20 mg per oral daily

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-03-01
• Completion: 2020-12-01
• First posted: 2018-08-28
• Last updated: 2018-08-28

Locations

7 sites across 1 country: Indonesia