51 Clinical outcomes of aCTG in primary midwife-led care COHORT STUDY Data collection The aCTG-innovation project started on January 1, 2015. After a run-in period, the inclusions for the cohort study were obtained from the ongoing project from August 1, 2016, to December 31, 2020. Midwifery practices were approached to obtain medical records of the women who gave consent to collect their data on maternal demographic and anthropometric characteristics, characteristics of the aCTG care process, medical and obstetric history, care during pregnancy, birth characteristics, and the postpartum period. Data were entered in the clinical database system Castor EDC. Prior to data cleaning, including screening data for logical errors and extreme value checks, we evaluated data entry error to ensure the integrity of the captured data. Double data entry was performed for 5% of all medical records and showed 1.19% errors in data entry. Percentages below 3% are considered acceptable; therefore, double-entering all data was not needed [25]. In cases where data were missing, midwives were contacted by the researcher to retrieve the missing data. When no data could be retrieved, women were excluded. Outcomes We used the core outcome set for pregnancy and childbirth, proposed by the International Consortium of Health Outcomes Measurements (ICHOM) [26]. The set was supplemented with outcome measures from the core outcome set for evaluating models of maternity care, published by the COMET initiative [27]. The process outcomes were aCTG location, gestational age at the aCTG, the conclusion of the aCTG-assessment, bi-disciplinary discussion (between primary care midwife and obstetrician), referral or transfer of care to OLC and the reason (non-reassuring aCTG: suboptimal aCTG, abnormal aCTG, or aCTG of insufficient quality), ultrasound abnormalities (in fetal growth, amniotic fluid, presentation of the fetus), other (hypertension, uterus contractions, persistently reduced fetal movements, noncephalic position after external cephalic version in primary care), and the total number of aCTGs in primary care. Maternal outcomes were level of care at the onset of labour, level of care at birth, place of birth, mode of birth (spontaneous vaginal birth, assisted vaginal birth, planned cesarean section (c-section), c-section during labour for suspected fetal distress or prolonged labour), induction of labour, pharmacological pain relief, perineal trauma, postpartum haemorrhage (PPH) (2000 mL), and maternal death. Perinatal outcomes were Apgar score (AS) < 7 at five minutes, birth weight (small for gestational age (90th percentile)), shoulder dystocia, consultation of a paediatrician, admission of the neonate, neonatal length of stay (number of consecutive days in the hospital up to seven days after birth), neonatal nutrition (intention, and at seven days postpartum) and a dichotomous composite measure of severe adverse neonatal outcomes occurring up to seven days after birth: 3
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