A Phase 3 interventional study of Dexamethasone and sterile water in HELLP Syndrome, sponsored by Universidad del Valle, Colombia. Status unknown at 1 site in Colombia. Open to female participants aged 10 Years to 48 Years. Per ClinicalTrials.gov, last updated 2010-06-07.
Sponsored by Universidad del Valle, Colombia · Phase 3, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under HELLP Syndrome; 8 are open to participants now.
This study's planned enrollment of 160 is close to the median of 167 across 12 interventional studies indexed under HELLP Syndrome.
Browse HELLP Syndrome studies →Universidad del Valle, Colombia is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
Also known as: steroid ev
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
Duration of hospitalization
Time frame: Average: 15 days
Recovery time of platelets to more than 100000/mm3
Time frame: Average:7 days
Recovery of AST, ALT and LDH
Time frame: Average: 10 days
Transfusion of blood products
Time frame: Average: 7 days
This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Universidad del Valle, Colombia