Dexamethasone Efficacy in HELLP I Syndrome

Universidad del Valle, Colombia

Status and phase: Unknown; Phase 3

Conditions: HELLP Syndrome

Treatments: Drug: Dexamethasone; Drug: sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT01138839

1625

COLCIENCIAS RC No. 334-2008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 10 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

sterile water

Placebo Comparator group

Description:

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.

Treatment:

Drug: sterile water

Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone