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
  Purpose

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.


Condition Intervention Phase
HELLP Syndrome
Drug: Dexamethasone
Drug: sterile water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidad del Valle, Colombia:

Primary Outcome Measures:
  • Duration of hospitalization [ Time Frame: Average: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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.
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138839

Contacts
Contact: Javier Fonseca, Dr 5725583912 jaenfo@gmail.com

Locations
Colombia
Universidad del Valle Recruiting
Cali, Valle, Colombia, 57
Contact: Javier Fonseca, Dr    5725583912    jaenfo@gmail.com   
Principal Investigator: Javier Fonseca, Dr         
Sponsors and Collaborators
Universidad del Valle, Colombia
Investigators
Principal Investigator: Javier Fonseca, Dr Universidad del Valle
  More Information

No publications provided

Responsible Party: Javier Fonseca, Universidad del Valle
ClinicalTrials.gov Identifier: NCT01138839     History of Changes
Other Study ID Numbers: 1625, COLCIENCIAS RC No. 334-2008
Study First Received: May 10, 2010
Last Updated: June 4, 2010
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Universidad del Valle, Colombia:
HELLP 1
Dexamethasone
Clinical trial

Additional relevant MeSH terms:
HELLP Syndrome
Syndrome
Disease
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014