Methods | Randomized blinded, placebo-controlled clinical trial (little information about study methods) | |
Participants | 26 women with gestational age between 27-37 weeks diagnosed with HELLP syndrome (criteria for diagnosis not clear). Exclusions: women with chorioamnionitis. |
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Interventions | Intervention group: (13) 10 mg dexamethasone IV every 12 hrs (2 doses) then 5 mg every 12 hrs (2 doses), total dose of 30 mg over 36 hours Control group: (13) no corticosteroid. All women were given a 6 g dose of magnesium sulfate (approximately 1.5 g/hr). All women gave birth within 12 hours |
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Outcomes | MAP, urinary output, serum glutanic aspartate aminotransferase (AST), alamine aminotransferase (ALT), LDH, and platelet count | |
Notes | Results were reported in graphs for platelet count, ALT levels, LDH levels and urine output. Not in a form in which we can enter results into RevMan ALT was listed as being measured along with AST but results for ALT were not reported in the results |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not stated (risk of bias assessment from translation notes). |
Allocation concealment? | Unclear | “sealed envelopes were distributed randomly to patients” (translation notes) |
Blinding? All outcomes |
Unclear | Not clear whether blinding or partial blinding was attempted |
Incomplete outcome data addressed? All outcomes |
Yes | No attrition or withdrawals reported. |
Free of other bias? | Yes | No baseline imbalance apparent. |
Overall risk of bias? | Unclear | Risk of bias assessment from translation notes. Possible selection bias (randomization methods not clear). Possible performance bias (there is no mention of blinding or use of a placebo) |