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. Author manuscript; available in PMC: 2014 Sep 23.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Aug 4;(8):CD001450. doi: 10.1002/14651858.CD001450.pub3
Methods Randomised controlled trial. Individual women.
Participants Inclusion criteria
  • Pregnant women, gestational age 16-20 weeks. Sufficient proficiency in English, expected to give birth in hospital and expected to remain in the Western Australia for childhood follow up.

  • N = 2834 with data available on 2801.

Interventions Experimental intervention: umbilical and uterine Doppler US - intense monitoring group
  • The intense group had ultrasound imaging and Doppler flow studies at approximately 18 weeks and then at 24, 28, 34 and 38 weeks.

  • Umbilical artery and arcuate artery within the placental vascular bed.

  • N = 1415.


Control/Comparison intervention: no Doppler US - regular group
  • Ultrasound scan at 18 weeks and any other tests only done at request of clinician.

  • N = 1419.


Multiple estimations were at 18, 24, 28, 34 and 38 weeks’ gestation
Outcomes Induction of labour; caesarean section; ultrasound information
Notes Perth (Aus) 1993 study in previous version of the review (Bricker 2007).
Authors report an increase in IUGR with the Doppler group (RR 2.07, 95% CI 1.34 to 3.21) but do not provide the data for us to enter into RevMan. They report “Multiple logistic regression analyses showed that the increased proportion of growth-restricted fetuses in the intensive arm was not due to a chance effect from differential clustering within the two groups…” though they go on to say that while this may have been a chance finding, it is possible that frequent exposure to ultrasound may have influenced fetal growth. This finding was not associated with increased perinatal morbidity and mortality, and follow up of these children at 1 year of age found that the difference in growth was no longer discernible. We are trying to contact the authors and are writing to the journal to seek further data
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes “…computer generated random numbers…”
Allocation concealment? Unclear
  • “..the woman was allocated to a group by a sealed-envelope technique prepared in blocks of 20…”

  • Suggest this is unclear because no mention of sequentially numbered envelopes not of their needing to be opaque.

Incomplete outcome data addressed?
All outcomes
Yes Describe any loss of participants to follow up at each data collection point:
  • 13/1415 (1%) in Doppler and 20/1419 (1%) in no Doppler.


Describe any exclusion of participants after randomisation:
  • Appeared to be none.

  • 66 (2.3%) multiple pregnancies excluded but we think before randomisation.


Was the analysis ITT? If not has the data been able to be re-included?
  • Appears to be ITT.

Free of selective reporting? Unclear We did not assess the trial protocol.
Free of other bias? Yes If the study was stopped early, explain the reasons:
  • Not stopped early for benefit or harm.


Describe any baseline in balance:
  • Groups similar in terms of: age, height, weight, marital status, race, parity, poor obstetric history and smoking.

  • 114 (intensive 50 and regular 64) women delivered in other hospitals and their outcomes were still assessed.


Describe any differential diagnosis:
  • Seems ok.