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.

Study Overview

• Status: Unknown
• Conditions: HELLP Syndrome
• Intervention / Treatment: Drug: sterile water; Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Javier Fonseca, Dr; Phone Number: 5725583912; Email: jaenfo@gmail.com

Study Locations

• Colombia
  • Valle
    • Cali, Valle, Colombia, 57
      • Recruiting
      • Universidad del Valle
      • Contact: Javier Fonseca, Dr; Phone Number: 5725583912; Email: jaenfo@gmail.com
      • Principal Investigator: Javier Fonseca, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	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 Names: steroid ev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of hospitalization	Average: 15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad del Valle, Colombia
• Investigators: Principal Investigator: Javier Fonseca, Dr, Universidad del Valle

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Estimate): June 7, 2010
• Last Update Submitted That Met QC Criteria: June 4, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Clinical trial; Dexamethasone; HELLP 1
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Pregnancy Complications; Hypertension, Pregnancy-Induced; Syndrome; HELLP Syndrome; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 1625; COLCIENCIAS RC No. 334-2008 (Other Identifier: colciencias)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No