Dexamethasone Efficacy in HELLP I Syndrome

HELLP Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01138839
• Other study ID #: 1625
• Secondary ID: COLCIENCIAS RC N
• Status: Recruiting
• Phase: Phase 3
• First received: May 10, 2010
• Last updated: June 4, 2010
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2010
• Source: Universidad del Valle, Colombia
• Contact: Javier Fonseca, Dr
• Phone: 5725583912
• Email: jaenfo[@]gmail.com
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HELLP Syndrome
• Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Colombia	Universidad del Valle	Cali	Valle

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Valle, Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

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