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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD008148. doi: 10.1002/14651858.CD008148.pub2
Methods Prospective, double blind, placebo controlled randomized clinical trial
Participants 132 eligible women with gestational age > 20 weeks (60 pregnant, 72 postpartum, mean age 25.3 years (range 14-44), mean parity 2.4, gestation 20-41 weeks)
Inclusion criteria: women diagnosed with class 1 or 2 HELLP syndrome pregnant or just after delivery (within 3 days of delivery)
Exclusion criteria: oral temperature > 37.5 degrees celsius, diabetic ketoacidosis, for women postpartum - more than 24 hours elapsed since diagnosis
(28% of the sample (women with GA 26-36 weeks) had betamethasone in the 2 weeks before delivery for fetal lung maturation.)
Interventions Intervention: dexamethasone (pregnant women 10 mg doses IV every 12 hours until delivery and 3 doses after delivery; postpartum women 3 10 mg doses)
Comparison group: placebo (sterile water IV) same regimen.
Treatment was discontinued if temp rose above 37.5c. All women received 1-1.5 g/hr of magnesium sulfate IV and anti-hypertensive and/or hydration therapy as required
Outcomes Duration of hospital stay (randomization to discharge).
Platelet count > 100,000 cells/mm3, LDH, AST.
Complications: acute renal failure, oliguria, pulmonary edema, eclampsia, infections, maternal death, need for platelet transfusion, need for plasma transfusion
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Stratified permuted blocks of 4.
Allocation concealment? Yes Consecutively numbered opaque envelopes, with active and placebo preparations packed in identical vials in sealed, coded boxes
Blinding?
All outcomes
Yes Adequate for women, staff and outcome assessors; placebo controlled trial with codes not broken until after analysis
Incomplete outcome data addressed?
All outcomes
Yes Adequate; 132 women were randomized, there were 6 protocol violations, (4 in intervention group and 2 in placebo) but authors report that they carried out an ITT analysis
Free of other bias? Yes No baseline imbalance apparent.
Overall risk of bias? No Low risk of bias.