Design Stepped-wedge cluster randomised controlled trial.
Setting Twelve randomised maternity units with ≥900 births/year in Scotland. Three additional units were included in a supplementary analysis to assess the effect across Scotland. The intervention commenced in March 2014 with follow-up until September 2016.
Intervention The PROMPT training package (Second edition), with subsequent unit-level implementation of PROMPT courses for all maternity staff.
Main outcome measures The primary outcome was the proportion of term babies with Apgar<75mins.
Results 87 204 eligible births (99.2% with an Apgar score), of which 1291 infants had an Apgar<75mins were delivered in the 12 randomised maternity units. Two units did not implement the intervention. The overall Apgar<75mins rate observed in the 12 randomised units was 1.49%, increasing from 1.32% preintervention to 1.59% postintervention. Once adjusted for a secular time trend, the ‘intention-to-treat’ analysis indicated a moderate but non-significant reduction in the rate of term babies with an Apgar scores <75mins following PROMPT training (OR=0.79 95%CI(0.63 to 1.01)). However, some units implemented the intervention earlier than their allocated step, whereas others delayed the intervention. The content and authenticity of the implemented intervention varied widely at unit level. When the actual date of implementation of the intervention in each unit was considered in the analysis, there was no evidence of improvement (OR=1.01 (0.84 to 1.22)). No intervention effect was detected by broadening the analysis to include all 15 large Scottish maternity units. Units with a history of higher rates of Apgar<75mins maintained higher Apgar rates during the study (OR=2.09 (1.28 to 3.41)) compared with units with pre-study rates aligned to the national rate.
Conclusions PROMPT training, as implemented, had no effect on the rate of Apgar <75mins in Scotland during the study period. Local implementation at scale was found to be more difficult than anticipated. Further research is required to understand why the positive effects observed in other single-unit studies have not been replicated in Scottish maternity units, and how units can be best supported to locally implement the intervention authentically and effectively.
Trial registration number ISRCTN11640515.
Bibliographical noteThe authors thank the CSO for funding the THISTLE study and the staff of the Scottish maternity units for their participation and continued support with the THISTLE Study. We would like to acknowledge the independent members of the Trial Steering Committee for their participation and continued support with the THISTLE Study. We also wish to thank Joannes Kerssens, Lizzie Nicholson, Mark Macartney, Carole Morris and Katrina Smith from eDRIS, ISD for continued support with the data management and Tracey Davidson, Bev Smith, Becky Bruce, Maria Ntessalen and Gladys McPherson based at CHaRT, University of Aberdeen for their logistic support. Finally, we would like to thank Dr Perla Marang van de Mheen for her insightful contribution in the interpretation of our results.
Data availability statement The study data are saved on the National Services Scotland Safe Haven, only accessible by ISD trained and approved member and will be archived as per ISD regulations. Further information on how to access these data and use the Safe Haven are available here: http://www.isdscotland.org/Products-and-Services/EDRIS/.
Funding The article outlines independent research funded by the Chief Scientist Office (CZH/4/893).
- apgar score
- intrapartum emergencies
- stepped-wedge trial
- training course
- SHOULDER DYSTOCIA
- PATIENT SAFETY
- OBSTETRIC EMERGENCIES