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

NCT02314286 | Unknown Phase 1

• 2 other identifiers: sor005514ctilSCRC14001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Pre-eclampsia

Keywords

Rosuvastatin; severe preeclampsia; 48 hours following delivery

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of Rosuvastatin on the severe preeclampsia resolution at 48 hours after delivery

  48 hours

Secondary Outcomes (7)

• 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

Study Arms (2)

control

PLACEBO COMPARATOR

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

treatment

EXPERIMENTAL

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

Interventions

Rosuvastatin DRUG

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.

Also known as: Stator

treatment

Placebo DRUG

control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who understand and sign the informed consent form.
• Women over the age of 18.
• Women between 24+0 weeks and 41+6 weeks gestation
• Women with singleton viable pregnancy.
• Have a diagnosis of severe pre-eclampsia

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Rosuvastatin Calcium; AtpH protein, E coli

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician at Obstetrics and Gynecology Division

Study Record Dates

• First Submitted: November 16, 2014
• First Posted: December 11, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 11, 2014

Record last verified: 2014-12