Methods | Sealed envelopes. | |
Participants | 2834 singleton pregnancies. Criteria for recruitment were gestational age 16-20 weeks, sufficient proficiency in English, expected to deliver at the hospital and an intention to remain in Western Australia so that childhood follow up would be feasible | |
Interventions | The ’regular’ group had an ultrasound examination at 18 weeks for fetal biometry, subjective amniotic fluid assessment and placental morphology and location, and any further scans in pregnancy were conducted on clinicians request. The ’intensive group’ had the aforementioned ultrasound examination, plus an amniotic fluid index and continuous wave Doppler ultrasound of the umbilical artery and an arcuate artery within the placental vascular bed at 18, 24, 28, 34 and 38 weeks’ gestation. The Doppler ultrasound parameter reportedwas systolic/diastolic ratio. Results of these examinations were recorded in the hospital chart, but no clinical management guidance was given | |
Outcomes | Obstetric interventions (antepartum and intrapartum) and perinatal outcome indices | |
Notes | The published study reports the results overall, but little data are available for extraction. The authors were contacted and provided unpublished data |
|
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Described as “computer-generated random numbers”. |
Allocation concealment? | Unclear | Described as “sealed envelopes”. |
Blinding? Women |
No | Not feasible. |
Blinding? Clinical staff |
No | Not feasible. |
Blinding? Outcome assessors |
No | Not feasible. |
Incomplete outcome data addressed? All outcomes |
Unclear | Some loss to follow up in both groups. “13 were lost to follow up in the intensive group of the trial and 20 in the regular” care group |
Free of selective reporting? | Yes | Selective outcome reporting bias not detected. |
Free of other bias? | Yes | Other bias not detected. |