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Rosuvastatin in Order to Induce Preeclampsia Resolution in Severe PET up to 48 Hours Following Delivery

NCT02314286 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Severe Pre-eclampsia

Interventions

DRUG

Rosuvastatin

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.

DRUG

Placebo

Sponsors & Collaborators

  • Soroka University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314286 on ClinicalTrials.gov