Egypt 2005.
Methods | Computer‐generated list of random numbers. Numbers then placed in sealed envelopes, and women asked to choose 1 envelope. Randomisation, drug prescription, and allocation key kept by 1 author with no role in participant follow‐up or outcome assessment. 3 women (2%) lost to follow‐up (1 aspirin, 2 control). | |
Participants | 139 women at 14‐16 weeks' gestation with abnormal uterine artery doppler (diastolic notch or resistance index > 90th percentile) and other risk factors for PE (previous history of PE/IUGR, essential HT, positive family history, underlying vascular disease, age < 20 years or > 40 years or gestational diabetes). Excluded: allergy to aspirin, peptic ulcer, other hepatic, renal, cardiovascular or thyroid disorder. | |
Interventions | Exp: aspirin 75 mg/day. Control: no treatment. | |
Outcomes | Women: PE (BP >/= 140/90 plus proteinuria > 300 mg/day); PE onset < 37 weeks; severe PE (BP > 160/110, proteinuria > 2 g, urine output < 500 mL/day, platelets < 100000/cmm, elevated liver enzymes); maternal bleeding. Babies: SGA (< 10th percentile); preterm birth; birthweight; neonatal bleeding; Apgar score at 1 and 5 minutes. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"Randomization was done using random number generated through a computer program" |
Allocation concealment (selection bias) | Low risk | Quote:"Computer‐generated list of random numbers. Numbers then placed in sealed envelopes, and women asked to choose 1 envelope. Randomisation, drug prescription, and allocation key kept by 1 author with no role in participant follow up or outcome assessment". |
Blinding (performance bias and detection bias) All outcomes | High risk | Although not stated explicitly, it seems reasonable to assume that the treatment was not blinded due to the daily administering of aspirin to the test group and no treatment to the control group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 women (2%) lost to follow‐up (1 aspirin, 2 control). Quote:"136 cases succeeded to complete the follow‐up period, whereas 3 cases were lost. All patients were analysed in the group to which they were allocated (intention‐to‐treat analysis) and lost patients were analysed, using either the last follow‐up report or applying the worst patient scenario (patients given aspirin had the worst outcomes and those with no treatment had the best outcomes). Only 1 patient was lost from the aspirin group, whereas the other 2 patients were from the control group. For all patients, the follow‐up was lost after 37 weeks." |
Selective reporting (reporting bias) | Low risk | All outcomes specified in the methods section of the paper are reported. However, no access to protocol. |
Other bias | Low risk | No significant differences in baseline characteristics. |