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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007529. doi: 10.1002/14651858.CD007529.pub2
Methods 2-arm randomised controlled trial with stratified block randomisation producing 4 groups: Caucasian primiparous and multiparous women, and Asian primiparous and multiparous women. Randomised in blocks of 8 using table of random numbers. However, the results are not reported by any of these subgroups - only Doppler vs CTG overall Randomisation was of individual women.
Participants Women with singleton fetuses with ultrasound examination showing the abdominal circumference < 2 SD of the mean for the gestational age fetal heart rate on charts recommended by British Medical Ultrasound Society. There was no gestational age constraint although all women were > 26 weeks gestation
N = 150 women.
Interventions Intervention: Doppler of umbilical artery and no CTG.
Comparison: CTG.
Outcomes Primary: duration of hospital antenatal admission, induction of labour rates
Secondary: number of investigations (CTG or Doppler), number of outpatient visits to hospital, emergency CS rate, length of stay on the NICU, birthweight, and 1 min and 5 min Apgar score
All women were sent a questionnaire asking their views on the process of their care
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Blocks of 8 using a table of random number.
Allocation concealment? Yes “…randomisation only possible by telephone …. sequentially numbered sealed opaque envelopes… ”
Incomplete outcome data addressed?
All outcomes
Yes No loss of participants at follow up.
No exclusion after the randomisation.
ITT analysis.
Free of selective reporting? Unclear We have not assessed the trial protocol.
Also, despite the stratified randomisation to look at ethnicity and parity, the results are not reported by any of these subgroups, only Doppler vs CTG overall
Free of other bias? Yes Study went to completion.
Basline in balance: more women had no live-in support at home in the CTG group Differential diagnosis: “…there was not a rigid protocol except that clinicians usually felt that a CTG record gave reassurance for 48-72 hours and a Doppler examination for a week or more … ”