48 Chapter 3 patient-reported outcome and experience measures along with process and clinical parameters. Research showed that women are highly satisfied with receiving MLCaCTG [17]. For further implementation, research into the process and health outcomes of women who receive aCTG in the primary care setting and their babies is needed. This study therefore aimed to evaluate: 1) process outcomes of the implementation of MLC-aCTG; 2) maternal- and perinatal outcomes of women receiving MLC-aCTG; 3) the incidence, outcomes, causes, and avoidability of serious adverse events (SAEs) attributable to the use of MLC-aCTG and potential prevention strategies for them. MATERIALS AND METHODS Study design This study comprised an evaluation of an ongoing innovation project, ‘MLC-aCTG in three regions in the Netherlands in which women consented for MLC-aCTG. We performed a prospective observational cohort study and a case series study of SAEs. The women included in the cohort study were provided with written and verbal information about the study’s aim, and gave their written consent for information to be obtained from their perinatal records. For the case series study, the women included gave their informed consent to participate in the aCTG innovation project; only pseudonymised data were used for this part. Setting and procedure In the Netherlands, risk selection and role division between the MLC and OLC is based on the obstetric indication-list. This document designates the appropriate level of care for over 100 obstetrical conditions [3]. One important aim of this model is to ensure safe midwife-led care for healthy women by performing risk selection. The CTG, a continuous electronic recording of the fetal heart rate, is obtained through an ultrasound transducer placed on the mother’s abdomen, and a second transducer to record the presence of any uterine activity. The maternal pulse is monitored via a finger probe. The fetal heart rate, maternal pulse, and uterine activity are monitored simultaneously. According to the obstetric indication-list, when an aCTG is indicated for a pregnant woman in MLC, the primary care midwife refers the woman to OLC for consultation. The woman receives an OLC-aCTG and ultrasound scan in the hospital, usually performed and assessed by a hospital-based midwife or resident under the supervision of an obstetrician. Blood pressure is measured as well. If all findings of CTG, ultrasound, and blood pressure are normal, the obstetrician will refer the woman back to MLC, where her antenatal care will continue. In case of increased risk or of complications, the care is continued in OLC (transfer of care). The innovation project, aCTG in MLC, was implemented in three regions in the Netherlands and started in 2015. ACTGs were performed for healthy pregnant women between 28 and 42 weeks
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