Dexamethasone Efficacy in HELLP I Syndrome

Phase 3

• Conditions: HELLP Syndrome
• Interventions: Drug: sterile water; Drug: Dexamethasone

• Registration Number: NCT01138839
• Lead Sponsor: Universidad del Valle, Colombia

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-10
• Status Verified: 2010-06
• Study First Submitted QC: 2010-06-04
• Last Update Submitted: 2010-06-04
• Study First Posted: 2010-06-07
• Last Update Posted: 2010-06-07
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sterile water	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.
Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Duration of hospitalization	Average: 15 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universidad del Valle; 🇨🇴 Cali, Valle, Colombia