| Methods | RCT. | |
| Participants | 30 postpartum women with a diagnosis of HELLP syndrome while pregnant from symptoms and laboratory findings. Hemolysis, elevated liver enzymes (AST > 48 IU/L, ALT > 24 IU/L) low platelets (< 100,000 cells/mm3) All women were delivered within 72 hrs of admission (IOL initiated with CS for fetal distress). Women randomized following delivery |
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| Interventions | Intervention group: immediately after delivery 10 mg dexamethasone IV, then 10 mg at 12 hrs, and 5 mg at 24 and 36 hrs (total dose over 36 hrs = 30 mg) Control group: no steroids. Women in both groups had anti-convulsive therapy (IV magnesium sulfate - bolus 4 g then 1 g/hr over 48 hrs). Anti-hypertensive therapy as required (> 160/110 mmHg) Careful monitoring in both groups (arterial BP and urine output monitored 2 hrly) and lab tests 6-12 hrly All women remained in ICU until symptoms and lab tests showed signs of remission |
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| Outcomes | Outcomes: Mean arterial BP, urine output, laboratory findings (AST, ALT, platelet count, hematocrit). Mean length of hospital stay | |
| Notes | ||
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Adequate sequence generation? | Unclear | Not described. |
| Allocation concealment? | Unclear | Women were “randomly assigned”. |
| Blinding? All outcomes |
Unclear | No blinding of women or clinical staff. It was not clear if outcome assessors were blind |
| Incomplete outcome data addressed? All outcomes |
Yes | All women seem to be accounted for in the analyses. 2 women died before delivery (before randomization) |
| Free of other bias? | Yes | Groups appear similar at baseline. Very little information on study methods |
| Overall risk of bias? | Unclear | Possible performance and selection bias, it was not clear how randomization was achieved or if blinding occurred |
ALT: alanine transaminase
ARDS: acute respiratory distress syndrome
AST: aspartate transaminase
BP: blood pressure
CS: caesarean section
DIC: disseminated intravascular coagulation
GA: gestational age
GI: gastrointestinal
HELLP: hemolysis, elevated liver enzymes and low platelets
hr: hour
hrly: hourly
ICU: intensive care unit
IOL: induction of labor
ITT: intention to treat
IM: intramuscular
IV: intravenous
LDH: lactate dehydrogenase
MAP: mean arterial pressure
RCT: randomized controlled trial
RDS: respiratory distress syndrome