Rosuvastatin in Order to Induce Preeclampsia Resolution in Severe PET up to 48 Hours Following Delivery
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|ClinicalTrials.gov Identifier: NCT02314286|
Recruitment Status : Unknown
Verified December 2014 by Ofer Beharier, Soroka University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Severe Pre-eclampsia||Drug: Rosuvastatin Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Rosuvastatin Use in Order to Induce Preeclampsia Resolution in Severe Preeclampsia Cases up to 48 Hours Following Delivery|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
Placebo Comparator: 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.
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.
Rosuvastatin is a hydrophilic statin, short treatment (hours to days) with this type of statin improved the outcome of patients during acute myocardial infarction, sepsis, contrast-induced nephropathy, hepatic ischemia/reperfusion injury, emphasizing its preferential pleiotropic effects. Currently, the FDA classiﬁes all statins as pregnancy category X and discourages their use during pregnancy due to higher abortion rate and teratogenicity that were observed in animals exposed to hydrophobic statins during pregnancy. Since the use of statins after delivery is allowed, the present study will aim to evaluate whether Rosuvastatin may accelerates preeclampsia resolution following delivery and potentially reduce postpartum preeclampsia complications.
Other Name: Stator
- To evaluate the effect of Rosuvastatin on the severe preeclampsia resolution at 48 hours after delivery [ Time Frame: 48 hours ]
- Time from delivery until reduction in general blood pressure [ Time Frame: 48 hours ]systolic pressure below 140mm\Hg or diastolic pressure below 90mm\Hg. Measurement will be carried out according to standard Protocol: before delivery, every 30 minutes during the first 2 hours post-delivery then every hour until discharge.
- Duration and dosage of hypertensive treatment due to severe hypertension (systolic greater than 160 mmHg or diastolic greater than 110 mmHg [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 48 hours ]
- Length assessment of intensive care unit hospitalization [ Time Frame: 48 hours and beyond ]
- Immunological assessment of the placenta [ Time Frame: 48 hours and beyond ]
We intend to test the following metrics:
- The amount and activity of NK cells in the placenta.
- The rate of secretion of angiogenic factors VEGF, SFLT-1, PLGF and inflammation factors TGF-ALFA I and IL-6.