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Dexamethasone Efficacy in HELLP I Syndrome

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ClinicalTrials.gov Identifier: NCT01138839
Recruitment Status : Unknown
Verified June 2010 by Universidad del Valle, Colombia.
Recruitment status was:  Recruiting
First Posted : June 7, 2010
Last Update Posted : June 7, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
HELLP Syndrome Drug: Dexamethasone Drug: sterile water Phase 3

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial
Study Start Date : October 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012


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 Name: steroid ev



Primary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: Average: 15 days ]

Secondary Outcome Measures :
  1. Recovery time of platelets to more than 100000/mm3 [ Time Frame: Average:7 days ]
  2. Recovery of AST, ALT and LDH [ Time Frame: Average: 10 days ]
  3. Transfusion of blood products [ Time Frame: Average: 7 days ]


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Ages Eligible for Study:   10 Years to 48 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Javier Fonseca, Universidad del Valle
ClinicalTrials.gov Identifier: NCT01138839     History of Changes
Other Study ID Numbers: 1625
COLCIENCIAS RC No. 334-2008 ( Other Identifier: colciencias )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2010

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

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