NCT01138839

Dexamethasone Efficacy in HELLP I Syndrome

Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Universidad del Valle, Colombia · Academic / Other
• Sex: Female
• Age: 10 Years – 48 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HELLP Syndrome

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2010-06-07
• Last updated: 2010-06-07

Locations

1 site across 1 country: Colombia