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Abstract
Objective To assess whether the implementation of an intrapartum training package (PROMPT (PRactical Obstetric Multi-Professional Training)) across a health service reduced the proportion of term babies born with Apgar score <7 at 5 min (<75mins).
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.
- intrapartum emergencies
- training course
- apgar score
- stepped-wedge trial
- obstetrics
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Footnotes
Contributors All members of the THISTLE group were involved in the development of the study and contributed its implementation. CW, DS, JC and TD developed and coordinated the implementation of the intervention. EL designed and conducted the statistical analysis with the support of GM and JN. All authors contributed to the data interpretation, manuscript writing and review and approved its final version. SB is the chief investigator and SB and TD are the guarantors. EL, CW, GM, DS,PL, JN, SB and TD acquired the funding.
Funding The article outlines independent research funded by the Chief Scientist Office (CZH/4/893).
Disclaimer The views expressed are those of the authors and the study sponsor and funders have had no role in the study design, collection, management analysis and interpretation of data, writing of the report and decision to submit the report for publication.
Competing interests EL is an employee of the University of Bristol which receives funding from PROMPT charity to pay part of EL’s salary. CW is seconded from North Bristol NHS Trust as the Lead Research Midwife to the PROMPT charity. DS is an invited member of GLOBE, an initiative funded by Ferring. TD is a Trustee of the PROMPT Maternity Foundation charity, which provides PROMPT Training. He is a consultant for Limbs & Things and Laerdal and paid speaker for Ferring Pharmaceuticals. CW, DS and JC are members of the PROMPT Maternity Foundation charity. The remaining authors have no competing interests.
Patient consent for publication Not required.
Ethics approval Ethics approval was obtained: REC reference 13/NS/0111.
Provenance and peer review Not commissioned; externally peer reviewed.
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/.