Davies 1992.
Methods | Randomised controlled trial. Individual women. Queen Charlotte's and Chelsea Hospital, London, UK. | |
Participants | Inclusion criteria
Exclusion criteria
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Interventions |
Experimental intervention: Doppler ultrasound of umbilical‐artery and uterine‐artery
Control/Comparison intervention: no Doppler ultrasound
Multiple estimations were at 20 and 32 weeks' gestation. Sample size calculation "to have an 80% chance at the 5% level of significance of demonstrating a 20% reduction in antenatal admissions during pregnancy in the doppler group." |
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Outcomes | Number of days of antenatal admission; number of CTG recordings and US scans; gestational age at birth; mode of birth; birthweight; Apgar scores; need for resuscitation (intermittent positive pressure ventilation either via a mask or endotracheal tube); admission to NICU; fetal and neonatal outcomes. The study was not designed to test the ability of Doppler ultrasound to reduce PNM, so the fact that there were more preventable deaths in the Doppler group is likely to be due to chance. However, the authors do theorise that it is possible that a woman's knowledge of a normal result may have resulted in her taking less notice of symptoms that might otherwise have resulted in a review of fetal well‐being. |
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Notes | London (UK) 1992 study in previous version of the review (Bricker 2007). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described; randomisation conducted in blocks of 500 and 200. |
Allocation concealment (selection bias) | Low risk | Allocation "by cards in sealed opaque envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding not possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Describe any loss of participants to follow‐up at each data collection point. Describe any exclusion of participants after randomisation:
Was the analysis ITT? If not, have the data been able to be re‐included?
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Selective reporting (reporting bias) | Unclear risk | There are discrepancies in the numbers of neonatal deaths between reports of this trial. We have used the numbers reported in the Lancet 1992 article, including early neonatal deaths added together with neonatal deaths. |
Other bias | Low risk | If the study was stopped early, explain the reasons:
Describe any baseline imbalance:
Describe any differential diagnosis:
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