| 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. |
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| Interventions | Intervention: Doppler of umbilical artery and no CTG. Comparison: CTG. |
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| 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 |
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| 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 … ” |