Dexamethasone Efficacy in HELLP I Syndrome
2 other identifiers
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 7, 2010
June 1, 2010
2.2 years
May 10, 2010
June 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of hospitalization
Average: 15 days
Secondary Outcomes (3)
Recovery time of platelets to more than 100000/mm3
Average:7 days
Recovery of AST, ALT and LDH
Average: 10 days
Transfusion of blood products
Average: 7 days
Study Arms (2)
sterile water
PLACEBO COMPARATORPregnant women will receive 2.5 cc of sterile water every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 doses after delivery.
Dexamethasone
EXPERIMENTALPregnant women in the experimental group will receive 10-mg doses (2.5 cc) of dexamethasone sodium phosphate intravenously every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 10-mg doses after delivery.
Interventions
Pregnant women in the experimental group will receive 10-mg doses (2.5 cc) of dexamethasone sodium phosphate intravenously every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 10-mg doses after delivery.
Pregnant women will receive 2.5 cc of sterile water every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 doses after delivery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- diabetic ketoacidosis
- oral temperature \> 37.5 grade
- Contraindication for use steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad del Valle
Cali, Valle del Cauca Department, 57, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Fonseca, Dr
Universidad del Valle
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2010
First Posted
June 7, 2010
Study Start
October 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
June 7, 2010
Record last verified: 2010-06