Mdoe 2015.
Methods | Prospective parallel randomised controlled trial. Funding: no details provided. |
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Participants |
Location: 2 settings in the United Republic of Tanzania. An urban setting at the Muhimbili National Hospital and rural setting at the Haydom Lutheran Hospital. In all settings fetal blood gas sampling or epidural analgesia were not available. Inclusion criteria: women with low risk, who consented and were in active labour with singleton pregnancies, cephalic presentation, normal FHR (120‐160 bpm) and with a cervical dilatation of ≤ 7 cm. Exclusion criteria: women arriving in second stage, no other exclusion criteria described. It appears 1376 women at Muhimbili National Hospital and 1623 women at Haydom Lutheran Hospital were recruited. A total of 2999 women were randomised. |
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Interventions | Intermittent auscultation with hand‐held Doppler (Doppler) comparing urban with rural setting (n = 1521 (not clear)). Frequency of intermittent auscultation and length of listening (timing) not described but stated as 'free play'. Unclear what 'free play' mean. Or intermittent auscultation with Pinard Feteoscope comparing urban with rural setting (n =1475 (not clear)). Frequency of intermittent auscultation and length of listening (timing) not described but stated as 'free play'. Unclear what 'free play' means. |
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Outcomes | Outcomes are not reported separately for primary and secondary outcomes. Outcomes reported were caesarean section; abnormal FHR defined as < 120 or > 160 bpm; admission to NNU; 5 minute Apgar score < 7; bag mask ventilation; fresh stillbirth; neonatal death. | |
Notes | Review author RM emailed Mdoe to seek further details to describe the interventions, in particular what 'free play' was. Clarification was also sought about the published data, as the outcome data presented did not correspond with the total number of participants identified. Mdoe responded stating that It is anticipated that the results of the trial will be published within the next 6 months and suggested to wait for this publication. No further details provided. This trial was only published as an abstract. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | From email correspondence and abstract stated: "randomisation". No further details provided. |
Allocation concealment (selection bias) | Unclear risk | From email correspondence confirmed '1 to 1 open label'. Allocation concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not stated, however it is unlikely that blinding would be possible with the nature of the interventions, as they were visibly different. Therefore considered as high risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No other details given. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | This is not stated and the numerical data provided had major numerical inconsistencies in the publication and could not be used for meta‐analysis. Unclear which numbers were due to loss of follow‐up. |
Selective reporting (reporting bias) | High risk | Prespecified outcomes and the outcomes reported do not match. |
Other bias | Unclear risk | This publication is only an abstract and it remains unclear if the groups were balanced at baseline. |
bpm: beats per minute CTG: cardiotocograph EFM: electronic fetal monitoring FHR: fetal heart rate NICU: neonatal intensive care unit NNU: neonatal unit SD: standard deviation