Dexamethasone Efficacy in HELLP I Syndrome

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01138839

Enrollment

160

Registered

2010-06-07

Start date

2009-10-31

Completion date

2012-12-31

Last updated

2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HELLP Syndrome

Keywords

HELLP 1, Dexamethasone, Clinical trial

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.

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.

Interventions

DRUGDexamethasone

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.

DRUGsterile 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

10 Years to 48 Years

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

Design outcomes

Primary

Measure	Time frame
Duration of hospitalization	Average: 15 days

Secondary

Measure	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

Countries

Colombia

Contacts

Primary ContactJavier Fonseca, Dr

jaenfo@gmail.com5725583912

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026