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

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soroka University Medical Center
• Treatments: Polystyrene sulfonic acid; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Women who understand and sign the informed consent form.

2. Women over the age of 18.

3. Women between 24+0 weeks and 41+6 weeks gestation

4. Women with singleton viable pregnancy.

5. Have a diagnosis of severe pre-eclampsia

Exclusion Criteria:

1. Eclampsia (convulsions)

2. Current use of statins

3. Women during active labor (5 cm and above)

4. 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)

5. A known or suspected adverse reaction in former statin use.

6. Transfer to a non-trial centre

7. Women who would like to breastfeed 24-48 hours after delivery