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Dexamethasone Efficacy in HELLP I Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Universidad del Valle, Colombia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT01138839
First received: May 10, 2010
Last updated: June 4, 2010
Last verified: June 2010

May 10, 2010
June 4, 2010
October 2009
December 2011   (final data collection date for primary outcome measure)
Duration of hospitalization [ Time Frame: Average: 15 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01138839 on ClinicalTrials.gov Archive Site
  • Recovery time of platelets to more than 100000/mm3 [ Time Frame: Average:7 days ] [ Designated as safety issue: No ]
  • Recovery of AST, ALT and LDH [ Time Frame: Average: 10 days ] [ Designated as safety issue: No ]
  • Transfusion of blood products [ Time Frame: Average: 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dexamethasone Efficacy in HELLP I Syndrome
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HELLP Syndrome
  • Drug: Dexamethasone
    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.
    Other Name: steroid ev
  • Drug: sterile water
    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
    Other Name: sterile water
  • Placebo Comparator: sterile water
    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.
    Intervention: Drug: sterile water
  • Experimental: Dexamethasone
    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: Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
10 Years to 48 Years
No
Contact: Javier Fonseca, Dr 5725583912 jaenfo@gmail.com
Colombia
 
NCT01138839
1625, COLCIENCIAS RC No. 334-2008
No
Javier Fonseca, Universidad del Valle
Universidad del Valle, Colombia
Not Provided
Principal Investigator: Javier Fonseca, Dr Universidad del Valle
Universidad del Valle, Colombia
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP