52 Chapter 3 AS < 4 at five minutes; perinatal death (after 28 +0 weeks gestation); ventilation with intubation; encephalopathy; meconium aspiration syndrome; brachial plexus injury; infant respiratory distress syndrome (IRDS); pneumothorax; necrotising enterocolitis (NEC); convulsions; sepsis; meningitis; other (additional information in Table S1). Analyses The details of the aCTG care process, characteristics and health outcomes of the pregnant women and their newborns from birth to seven days postpartum were analysed with descriptive statistics and presented as frequencies and percentages for categorical variables and means and standard deviations for continuous variables. The categories for the ethnic background were not filled in uniformly by midwives and were therefore unreliable. We therefore classified ethnicity as ‘Dutch’ or ‘non-Dutch.’ Socioeconomic status (SES) was based on the mean household income level of the respondent’s neighbourhood, as determined by the first four digits of the women’s postal codes. We stratified the results by the three aCTG indications. Missing data are presented in the Tables. Analyses were conducted using the Statistical Package for Social Sciences (SPSS) version 26.0 for Windows (SPSS Inc., Chicago, IL, USA). CASE SERIES STUDY Data collection To be transparent and as complete as possible about the safety of aCTG in MLC, we investigated potential serious adverse events in all women who received an MLCaCTG during the aCTG-innovation project from January 1, 2015 to December 31, 2020. Women who agreed to have an MLC-aCTG consented to the regional quality committees to collect data for cases with a potential SAE to evaluate whether the SAE was attributable to the aCTG-innovation project. We developed an online case record form (CRF) in Castor EDC for in-depth anonymous information about the potential SAEs. A link to the CRF was sent by email to the involved healthcare professional. We asked for details about the pregnancy, the situation where the potential SAE had occurred, the circumstances, and the procedure that followed. All cases were reported anonymously, and references to the identity of the healthcare professional and the hospital were deleted before analysis. Outcomes A potential SAE was described as a perinatal death or severe perinatal morbidity defined as admission of the neonate to NICU after an aCTG was performed in MLC.
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