Methods | Randomised controlled trial, pilot study recruiting alongside another larger trial | |
Participants | 167 women with singleton pregnancies 24 to 36 weeks; outpatients; previous normal anatomy scan; ultrasound showing abdominal circumference < 10th percentile, 2 measures of umbilical artery Doppler resistive index < 95th centile, no oligohydramnios | |
Interventions | Twice-weekly versus fortnightly fetal surveillance. Surveillance methods include biophysical profile, nonstress tests, umbilical artery and middle cerebral artery Doppler, growth scans and uterine artery Doppler | |
Outcomes | Neonatal; gestational age at delivery, umbilical artery resistive index at delivery, abnormal umbilical artery at delivery, female sex, birthweight, birthweight < 10th percentile, ponderal index, ponderal index < 10th percentile, admission to neonatal nursery, neonatal hospital stay, acidosis at birth, hypogylcemia Maternal: spontaneous onset of labour, induction of labour, caesarean delivery, caesarean delivery for fetal distress, pre-eclampsia, gestational hypertension |
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Notes | Sample size calculated for main study, no prespecified single primary outcome for this pilot complementary study | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer-generated numbers. |
Allocation concealment? | Yes | Central telephone randomisation service. |
Blinding? All outcomes |
Unclear | Not feasible to blind participant and unclear if clinician or outcome assessors were blinded |
Incomplete outcome data addressed? All outcomes |
Yes | No loss to follow up documented. |