Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 152 for:    severe preeclampsia AND Pregnancy Complications

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Ofer Beharier, Soroka University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Pre-eclampsia Drug: Rosuvastatin Drug: Placebo Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Placebo
Experimental: 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.
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.
Other Name: Stator




Primary Outcome Measures :
  1. To evaluate the effect of Rosuvastatin on the severe preeclampsia resolution at 48 hours after delivery [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Length assessment of intensive care unit hospitalization [ Time Frame: 48 hours and beyond ]
  7. Immunological assessment of the placenta [ Time Frame: 48 hours and beyond ]

    We intend to test the following metrics:

    1. The amount and activity of NK cells in the placenta.
    2. The rate of secretion of angiogenic factors VEGF, SFLT-1, PLGF and inflammation factors TGF-ALFA I and IL-6.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Ofer Beharier, Physician at Obstetrics and Gynecology Division, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02314286     History of Changes
Other Study ID Numbers: sor005514ctil
SCRC14001 ( Other Identifier: soroka )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Keywords provided by Ofer Beharier, Soroka University Medical Center:
Rosuvastatin
severe preeclampsia
48 hours following delivery
Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors