Rosuvastatin Use in Order to Induce Preeclampsia Resolution in Severe Preeclampsia Cases up to 48 Hours Following Delivery
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 主要终点
- To evaluate the effect of Rosuvastatin on the severe preeclampsia resolution at 48 hours after delivery
研究概览
简要总结
Prospective randomized single blind trial. Study population are women diagnosed with severe pre-eclampsia during singleton pregnancy, between 24+0 weeks and 41+6 weeks gestational age. The purpose of the study is to evaluate the effect of Rosuvastatin on the severe preeclampsia resolution at 48 hours after delivery. After screening and signing an informed consent form, before entering delivery room, a randomization 1:1 will be carried. 50 women will be in the treatment arm while 50 will be in the control arm. Both groups will be treated according to ACOG (The American College of Obstetricians and Gynecologists has the following clinical guidelines related to deliveries before 39 weeks) guidelines. In addition, following randomization experimental group will be treated with Rosuvastatin 40mg that will be administrated orally with or without food. Treatment will be carried within the first hour following delivery. Another dose will be given 24 hours after first administration. Control group will be treated with placebo.
详细描述
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks' postpartum. It is clinically defined by as blood pressure ≥140 mmHg systolic and ≥90 mmHg diastolic diagnosed for the first time after 20 weeks' gestation together with >300mg proteinuria/24 hours.
The global incidence of preeclampsia has been estimated at 5-14% of all pregnancies. Pre-eclampsia affects approximately 6-8% of all pregnancies worldwide. Pre-eclampsia affects 3-5% of all first time pregnancies, but early severe pre-eclampsia occurs in only 1:200 pregnancies.
Significant risk factors for pre-eclampsia are as follows: Nulliparity, age >40 years, black race, family history, chronic renal disease, chronic hypertension, antiphospholipid syndrome, diabetes mellitus , multiple gestation and high body mass index.
Mild preeclampsia is defined as the presence of hypertension (BP ≥140/90 mm Hg) on 2 occasions, at least 6 hours apart, but without evidence of end-organ damage.
Severe preeclampsia is defined as the presence of 1 of the following symptoms or signs in the presence of preeclampsia:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who understand and sign the informed consent form.
- •Women over the age of
- •Women between 24+0 weeks and 41+6 weeks gestation
- •Women with singleton viable pregnancy.
- •Have a diagnosis of severe pre-eclampsia
排除标准
- •Eclampsia (convulsions)
- •Current use of statins
- •Women during active labor (5 cm and above)
- •Contraindications to statin use (other than pregnancy) including:
- •Hypersensitivity to Rosuvastatin or any of its excipients
- •Active liver disease or elevation of serum Transaminases >3 ULN) believed to be unrelated to pre- eclampsia.
- •Pre-pregnant renal insufficiency (creatine clearance less than 30 ml/min)
- •Concomitant administration of medications known to interact with Rosuvastatin (e.g. Cimetidine)
- •A known or suspected adverse reaction in former statin use.
- •Transfer to a non-trial centre
- •Women who would like to breastfeed 24-48 hours after delivery
研究组 & 干预措施
control
After signing an informed consent form and filling a demographic and medical questionnaire, a randomization 1:1 will be carried. 50 women will be in the control arm. the group will be treated according to ACOG guidelines (Appendix). After the delivery, a small placenta sample will be collected.
Control group will be treated with placebo.
干预措施: Placebo (Drug)
treatment
50 women will be in the treatment arm. the group will be treated according to ACOG guidelines (Appendix). After the delivery, a small placenta sample will be collected. In addition, following randomization experimental group will be treated with Rosuvastatin 40mg that will be administrated orally with or without food. Treatment will be carried within the first hour following delivery. Another dose will be given 24 hours after first administration. Control group will be treated with placebo.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
To evaluate the effect of Rosuvastatin on the severe preeclampsia resolution at 48 hours after delivery
时间窗: 48 hours
次要结局
- Time from delivery until reduction in general blood pressure(48 hours)
- Duration and dosage of hypertensive treatment due to severe hypertension (systolic greater than 160 mmHg or diastolic greater than 110 mmHg(48 hours)
- Evaluation of renal function through urine Protein / creatinine ratio measurement will be examined before delivery and 6, 12, 18, 24 hours post-delivery. In addition the time from delivery to polyuria will be assessed via measuring urine output per hour.(48 hours)
- Rate of liver transminases resolution. Samples will be taken before delivery and every 6 hours post-delivery (part of the routine follow-up of preeclampsia).(48 hours)
- Examining time to thrombocytopenia resolution. Samples will be taken before delivery and every 6 hours post-delivery (part of the routine follow-up of preeclampsia).(48 hours)
- Length assessment of intensive care unit hospitalization(48 hours and beyond)
- Immunological assessment of the placenta(48 hours and beyond)
研究者
Ofer Beharier
Physician at Obstetrics and Gynecology Division
Soroka University Medical Center