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.) |
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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 |
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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 |
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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. |