Dexamethasone Efficacy in HELLP I Syndrome
Primary Purpose
HELLP Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Dexamethasone
sterile water
Sponsored by
About this trial
This is an interventional treatment trial for HELLP Syndrome focused on measuring HELLP 1, Dexamethasone, Clinical trial
Eligibility Criteria
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
Sites / Locations
- Universidad del ValleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
sterile water
Dexamethasone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Duration of hospitalization
Secondary Outcome Measures
Recovery time of platelets to more than 100000/mm3
Recovery of AST, ALT and LDH
Transfusion of blood products
Full Information
NCT ID
NCT01138839
First Posted
May 10, 2010
Last Updated
June 4, 2010
Sponsor
Universidad del Valle, Colombia
1. Study Identification
Unique Protocol Identification Number
NCT01138839
Brief Title
Dexamethasone Efficacy in HELLP I Syndrome
Official Title
Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad del Valle, Colombia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Treatment of HELLP syndrome usually is restricted to measures of support and treatment of complications. In 2005, in a subgroup analysis we showed that, among patients with HELLP 1, there were a shorter average time to platelet recovery and less duration of hospitalization in women who received dexamethasone therapy, however the importance of this finding is diminished because this was an unplanned analysis and the severity of the disease was not taken into account at randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HELLP Syndrome
Keywords
HELLP 1, Dexamethasone, Clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sterile water
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
steroid ev
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sterile water
Intervention Description
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
Primary Outcome Measure Information:
Title
Duration of hospitalization
Time Frame
Average: 15 days
Secondary Outcome Measure Information:
Title
Recovery time of platelets to more than 100000/mm3
Time Frame
Average:7 days
Title
Recovery of AST, ALT and LDH
Time Frame
Average: 10 days
Title
Transfusion of blood products
Time Frame
Average: 7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Fonseca, Dr
Phone
5725583912
Email
jaenfo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Fonseca, Dr
Organizational Affiliation
Universidad del Valle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad del Valle
City
Cali
State/Province
Valle
ZIP/Postal Code
57
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Fonseca, Dr
Phone
5725583912
Email
jaenfo@gmail.com
First Name & Middle Initial & Last Name & Degree
Javier Fonseca, Dr
12. IPD Sharing Statement
Learn more about this trial
Dexamethasone Efficacy in HELLP I Syndrome
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