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
Recruitment status was Recruiting
Sponsor:
Universidad del Valle, Colombia
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
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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
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 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 May 16, 2013