Ali 2017.
Methods | RCT: NCT02696577 | |
Participants | 80 women randomised Inclusion criteria: 20–35 years; 28‐30 weeks' gestation; pregnancy complicated with asymmetrical IUGR (diagnosed by 2D trans‐abdominal US when the abdominal circumference was reduced out of proportion to other fetal biometric parameters and was below the 10th percentile so there was an increased HC:AC ratio); with normal Doppler indices in uterine and umbilical arteries at time of recruitment (the normal value of S/D ratio was from 2.5 to 3.5; RI was from 0.60 to 0.75 and PI was from 0.96 to 1.270, respectively). Exclusion criteria: ≤ 20 and ≥ 35 years; any hypertensive disorder; diabetes mellitus; smokers; multiple gestations, low amniotic fluid volume; premature prelabour rupture of membranes; antepartum haemorrhage and fetal congenital anomalies; women with abnormal Doppler indices, absent diastolic flow or reversed flow. Setting: Assiut Woman’s Health Hospital, Egypt |
|
Interventions |
SUPPLEMENTATION + OTHER AGENT: DHA + EPA + wheat‐germ oil + aspirin versus aspirin Group 1: fish oil (1000 mg = DHA 9%, EPA 13%) plus 100 mg wheat‐germ oil (LA 52%‐59%) as a source of vitamin E, and aspirin 81 once daily: n = 40 Group 2: aspirin 81 once daily: n = 40 Timing of supplementation: 6 weeks (from ˜28‐30 weeks GA) DHA + EPA dose/day: low: 90 mg DHA + 130 mg EPA |
|
Outcomes |
Women/birth: gestational length; caesarean section; Doppler blood flow in uterine and umbilical arteries Babies/infants/children: birthweight; perinatal mortality; admission to NICU |
|
Notes |
Funding: not reported Declarations of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number table |
Allocation concealment (selection bias) | Low risk | Quote: "Allocation concealment was done using serially numbered closed opaque envelopes. Each envelope was labelled with a serial number and had a card noting the intervention type. Allocation never changed after opening the closed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 12/80 (15%) participants lost to follow‐up (6/40 in both intervention (2 failure of treatment and 4 lost to follow‐up) and control group (3 failure of treatment and 3 lost to follow‐up). |
Selective reporting (reporting bias) | Unclear risk | With no access to a trial protocol it was not possible to assess selective reporting confidently. |
Other bias | Low risk | Baseline characteristics appeared similar, no obvious source of other bias identified. |