Effect of Rosuvastatin on the Clinical Features of Preeclampsia

NCT04303806 | Unknown Phase 2

• 1 other identifier: rosuvastatin on preeclampsia
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary outcome will be the effect of rosuvastatin on the resolution of biochemical features associated with severe PE (↑CRP and IL6). .

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• the effect of rosuvastatin on the clinical features of preeclampsia

  The primary outcome will be the effect of rosuvastatin on the resolution of biochemical features associated with severe PE (↑CRP and IL6).

  baseline

Study Arms (2)

Group 1

EXPERIMENTAL

40 preeclamptic parturient receive 20 mg rosuvastatin orally once daily.

Drug: rosuvastatin

Group 2

EXPERIMENTAL

40 preeclamptic parturient receive 40 mg rosuvastatin orally once daily.

Drug: rosuvastatin

Interventions

rosuvastatin DRUG

receive rosuvastatin orally once daily.

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-35 years.
• Singleton nonanomalous pregnancy (confirmed with an ultrasound examination).
• Normal lipid profile and normal liver transaminases.
• WBCs (4-11\*103/mm3).
• CRP \< 3 mg/L.

You may not qualify if:

• Parturient's refusal.
• Women with history of cardiac, respiratory, renal, neurologic or endocrine diseases.
• Contraindications for statin therapy (eg, hypersensitivity to rosuvastatin, recent or active liver disease).
• Concomitant therapy with fibrates, niacin, cyclosporine, clarithromycin, or erythromycin.
• Inability to tolerate oral medications secondary to severe nausea and vomiting of pregnancy.
• Multifetal gestation or fetal demise.
• Fetal abnormalities.
• Emergency surgeries.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Rosuvastatin Calcium

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

Central Study Contacts

Sara Mohamed, M.B.B.Ch.,M.Sc.

CONTACT

+201061092528; saramansourmansour1@gmail.com

Ragaa Ahmed, MD

CONTACT

+201001741748; ragaanesthesia@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: computer generated randomization will be conducted in a Women's Health Hospital, Assuit University. Neither the doctor "investigator" nor the participant "parturient" will be aware of the group allocation or the drug used. The study drugs will be prepared by one of the supervisor anesthesia (not included in the procedure, observation or in data collection)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer on anasthesia and icu department

Model Details: . They will be randomly allocated into two equal groups of 40 parturient each: Group 1: 40 preeclamptic parturient receive 20 mg rosuvastatin orally once daily. Group 2: 40 preeclamptic parturient receive 40 mg rosuvastatin orally once daily

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: March 11, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share