None listed
Conditions
Brief summary
Preeclampsia is pregnancy specific and complicates 5-8%. It is the leading cause of maternal and fetal morbidity and mortality. It is thought to occur as a result of abnormal attachment of the placenta to the uterine wall. This leads to a lack of oxygen and nutrient supply to the placenta. The ‘stressed’ and oxygen starved placenta releases ‘toxins’ that spread throughout the mother’s bloodsteam. They cause widespread injury of the mother’s blood vessels which then cause further damage to major organs: liver, kidneys and haematological impairment, nerves and the brain (causing seizures). Despite considerable research the only treatment available is termination of the pregnancy or delivery. In women that develop the disease early in pregnancy this exposes the fetus to considerable risk of the serious complications of preterm delivery. Pravastatin is a drug commonly taken by non-pregnant adults to lower the cholesterol in the blood. Importantly however, more recent research has found these drugs have also been shown to protect blood vessels. Therefore, it is possible they could mitigate the damage caused by the ‘toxins’ coming out of the placenta that injure the maternal blood vessels. If so, it could be potentially used as a treatment for severe preeclampsia. Just possibly, giving this drug to women with preterm preeclampsia might sufficiently quench the injury to the mother’s internal organs, allowing the pregnancy to safely continue to a gestation where the fetus is much less premature. Impressively, pravastatin has been tested in many animal models of preeclampsia and found to improve the disease. Importantly pravastatin didn’t cause harm in these animal models or when taken inadvertently in human case studies to either the mother or the fetus/neonate. We therefore propose a proof of concept early phase unblinded single arm study on the effect of pravastatin on the clinical course of early onset severe preeclampsia in humans. We will recruit 12 women and treat them with 40mg daily pravastatin. Inclusion criteria will be gestation 23+0 to 27+6 weeks, singleton pregnancy, with diagnosis of preeclampsia (increased blood pressure and high levels of protein in the urine).
Interventions
40mg oral pravastatin daily to women with early onset preeclampsia between 23 and 27+6 weeks gestation until delivery
Sponsors
The Mercy Hospital for Women
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
We will include women with a singleton pregnancy between 23+0 weeks to 32+6 weeks, diagnosed with preeclampsia as per the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines, confined to proteinuric preeclampsia between 0.5 – 1.5g per 24hour period at recruitment. This is because it is likely those with other organ involvement, or severe fetal growth restriction, are likely to be offered delivery very soon and it is unlikely there will be an adequate window of opportunity for the pravastatin to have effect. Further inclusion criteria: - the admitting clinicians have already made the decision not to immediately deliver. - no major anomalies on morphology ultrasound - Patient is capable of understanding the study and their involvement in it.
Exclusion criteria
- The presence of growth restriction (<10th percentile) at the time of involvement - Obvious organ involvement other than renal at the time of recruitment - Current use of statins - Contraindication to statins (liver failure, muscular disease, hypersensitivity, current use of erythromycin) Note: these are only exclusion criteria at the time of recruitment. If these complications develop, patients will remain in the study.
Outcome results
None listed