Hans van den Heuvel

10 After randomisation for telemonitoring, the participant will be trained in using the medical devices involved in the system (Sense4Baby CTG system and the Microlife Watch BP, both CE marked). The training will be conducted using standardized instructions of use. The instructions include a contact sheet with telephone numbers for technical or health related questions, accessible 24/7. Each participant will receive an individual treatment plan according to national and/or local guidelines, including fetal CTG monitoring and blood pressure measurement, both once daily. Participants at home are contacted by phone every day by the telemonitoring team, to discuss present symptoms or questions regarding the pregnancy. Possible protocolled steps in the management, after the uploaded test results are checked, are: 1) expectant management, 2) same-day clinical assessment (e.g. in case of CTG abnormalities, rise in BP or symptoms) or 3) if necessary clinical admission. The participant will visit the outpatient clinic at least once a week for real-time contact and when needed ultrasound assessment, blood or urinary analysis. Should hospital admission be necessary in case of change in clinical presentation or deterioration (e.g. non-reassuring CTG, hypertension, contractions, antepartum haemorrhage, signs of infection, maternal distress or technical difficulties), the patient will be monitored in the hospital as per local protocol and all data of interest during the admission will be collected. In the case this same participant can be discharged from ward again (e.g. after treatment optimisation for hypertension), she may go home with telemonitoring - as per randomisation- until delivery. All consultations in the outpatient department and possible ward admissions during pregnancy will be recorded for the study. Control group: hospital admission Pregnant women allocated to hospital admittance will receive standard obstetric care according to national and local guidelines and current state of the art, including daily fetal monitoring and blood pressure measurements. All participating centres committed to following guidelines for different diagnoses and management as set by the Dutch Society of Obstetrics and Gynecology. A typical regime on ward includes vital parameter check (blood pressure, temperature on indication) by obstetric nurses, daily cardiotocography and daily rotations for iby a resident in obstetrics and gynaecology, supervised by an obstetrician, for interpretation of results and further management. Blood and/or urine sampling and fetal ultrasound will be performed when indicated and according to local protocol. In case the necessity of hospital admission is no longer present, the patient may be discharged and if necessary admitted to ward again, as per randomisation, not allowing cross-over to telemonitoring. Outcome measures The primary outcome is maternal and fetal/neonatal safety during perinatal care from study inclusion onwards by recording incidence of perinatal mortality and maternal and neonatal morbidity. The composite of adverse perinatal outcome is defined as: perinatal mortality HOTEL TRIAL STUDY PROTOCOL 169