| Methods |
Quote:"Randomly allocated to group A or B", no other information available. 8.8% (9/102) excluded from analysis (2 controls lost to follow‐up, 4 treatment and 3 controls had a miscarriage before 16 weeks). |
| Participants |
102 women at high risk of PE or IUGR; for example, if several previous complicated pregnancies or vascular risk factors such as essential hypertension (BP > 160/95) or a family history of hypertension.
Excluded: women with secondary hypertension or known or suspected renal disease. |
| Interventions |
Exp: aspirin 150 mg and dipyridamole 300 mg daily, from 3 months until delivery.
Control: no antiplatelet agent. |
| Outcomes |
Women: PIH (BP at least 140/85 mmHg; PE; caesarean section; abnormal bleeding during delivery or caesarean section; abruption; headache.
Babies: stillbirth; neonatal death; fetal malformation; birthweight < 10th and < 3rd centile (livebirths only); haemorrhagic complication (undefined). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote:"Randomly allocated to group A or B"; no other information available. |
| Allocation concealment (selection bias) |
Unclear risk |
Quote:"Randomly allocated to group A or B"; no other information available. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Quote:"For ethical reasons the study was not double blind" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
8.8% (9/102) excluded from analysis (2 controls lost to follow‐up, 4 treatment and 3 controls had a miscarriage before 16 weeks); attrition balanced across groups. |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes are reported. However, no access to protocol. |
| Other bias |
Low risk |
Quote:"Our empirical selection of patients did not lead to a very homogenous population, but the heterogeneity was distributed evenly between the groups (table 1), so it is unlikely to bias results." |
