Dexamethasone Efficacy in HELLP I Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial

Conditions
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HELLP Syndrome

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: sterile water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sterile water<br>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<br>* 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<br>|
| Experimental: Dexamethasone<br>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<br>* 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.<br>* Other names: steroid ev;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization |  | Average: 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HELLP 1, Dexamethasone, Clinical trial