USA 1997.
Methods | Quote: "Randomly assigned", no further information. | |
Participants | 19 women with antiphospholipid antibodies and </= 2 previous miscarriages with no other antiphospholipid antibody‐related complications. Gestational age not described. Excluded: previous thrombosis, early onset PE, thrombocytopenia. |
|
Interventions | Exp: aspirin 81 mg/day throughout pregnancy. Control: usual care. | |
Outcomes | Babies: fetal death; SGA (< 5th percentile); fetal distress at term (not defined). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned", no further information. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomly assigned", no further information. |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding not mentioned but aspirin was compared to usual care (not placebo) so likely not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attritions/exclusions not explicitly reported in article but data in Table I indicates that there were none. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available and outcomes not clearly specified in methods section or elsewhere. Therefore, insufficient information to judge. |
Other bias | Unclear risk | Baseline characteristics: quote: "The patients' obstetric histories… and antiphospholipid antibody test results are summarised in Table I. None of the differences between groups was statistically significant." However, demographic details of groups (e.g. age, weight, etc) not provided. |