HELLP Syndrome Clinical Trial
Official title:
Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial
The purpose of this study is to determine the efficacy of dexamethasone for treatment of HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 10 Years to 48 Years |
Eligibility |
Inclusion Criteria: - Women who were at >20 weeks of gestation or during the first 3 days of puerperium if hypertension developed during the pregnancy or the puerperium with: - platelet count, < or = 50,000/mm3; aspartate aminotransferase (AST), > or = 70 U/L; lactate dehydrogenase (LDH), > or = 600 U/L. - Women who consent to be included informed consent by signature Exclusion Criteria: - diabetic ketoacidosis - oral temperature > 37.5 grade - Contraindication for use steroids |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad del Valle | Cali | Valle |
Lead Sponsor | Collaborator |
---|---|
Universidad del Valle, Colombia |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of hospitalization | Average: 15 days | No | |
Secondary | Recovery time of platelets to more than 100000/mm3 | Average:7 days | No | |
Secondary | Recovery of AST, ALT and LDH | Average: 10 days | No | |
Secondary | Transfusion of blood products | Average: 7 days | No |
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