The HOME (Home Monitoring of High-risk Pregnancies) study: a study protocol for an observational study of a telemedicine assisted follow-up at home versus hospitalization

Åsa Henning Waldum¹Aase Serine Devold Pay^2,3Gunvor Aasbø⁴Vinod Kumar Mishra⁵Meryam Sugulle^1,6Anne Cathrine Staff^1,6*

• ¹Department of Obstetrics and Gynaecology, Oslo University Hospital, Oslo, Nordland, Norway
• ²Department of Gynecology and Obstetrics, Bærum Hospital, Vestre Viken Hospital Trust, Drammen, Norway
• ³Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway
• ⁴University of Oslo, Oslo, Oslo, Norway
• ⁵Oslo University Hospital, Oslo, Nordland, Norway
• ⁶Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway

Background: Pregnancies at high risk for adverse health outcomes for mother and offspring often require long-term antenatal hospitalization and/or frequent outpatient visits. We have developed a telemonitoring home care service for high-risk pregnancies, integrated in the Electronic Patient Journal System of our Department. We will compare clinical safety, patient reported outcome measures, and use of healthcare resources compared to standard practice for hospital admissions and/or outpatient visits. Method: The Home Monitoring of High-risk Pregnancies study is an ongoing observational study. Eligible women with a pregnancy requiring intensified obstetric follow-up (e.g. preterm premature rupture of membranes, hypertensive disorders of pregnancy or a previous adverse obstetric outcome) are offered study inclusion to either standard care at the hospital or the home telemonitoring group, pending on available home monitoring equipment. Pregnant women included for home monitoring will be telemonitored according to relevant clinical practice for in-patients, including use of cardiotocography, blood pressure monitoring, C-reactive protein and temperature measurement, and will provide self-registration of relevant clinical symptoms. A telecare patient communication system prompts rapid contact with the hospital in case of unfavorable registered clinical parameters or subjective symptoms. The home telemonitored women attend hospital visits with fetal ultrasound assessment at individually assigned intervals. Patients undergoing in-hospital care serve as control group in this study and receive standard care.The primary outcome is a composite of severe maternal and perinatal adverse outcomes [sepsis, eclampsia, cerebral hemorrhage, acute respiratory distress syndrome, liver rupture, pulmonary embolism. amniotic fluid embolism, HELLP (hemolysis, elevated liver enzymes, low platelets) /ELLP (HELLP without hemolysis), and DIC (disseminated intravascular coagulation)], including fetal or neonatal mortality, maternal mortality or signs of severe organ damage. Secondary outcomes include other adverse maternal and fetal/neonatal health outcomes, patient reported outcomes and economic cost analyses. Discussion: The implementation of home care service for women with high-risk pregnancies requiring intensified surveillance, is expected to be equally safe, more comfortable and convenient for the women, and with less economic costs.Trial registration: Clinicaltrial.gov NCT05763069.