HOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial

In this study we aim to study the effects of self-management at home in combination with telemedicine in high-risk pregnancies on safety, cost-effective and patient satisfaction. Pregnancies complicates with mild preeclampsia, intrauterine growth restriction, preterm rupture of membranes, recurrent reduced fetal movements, fetal anomalies requiring daily monitoring (e.g. gastroschisis) or fetal demise in obstetric history will be eligible for the study.

In this study we will train the use of the system to high-risk pregnant women teaching them how to handle the equipment. We expect that this facilitates the use of telemedicine at home irrespective of intelligence, technical skills, language barriers and socio-economic background.

In this study the following specific objectives will be addressed:
1) to determine whether this novel obstetric care strategy is as safe as the currently provided care during hospital admission;
2) to evaluate the feasibility and cost-effectiveness of telemedicine in high-risk pregnant women remaining at home;
3) to evaluate patient experience and satisfaction with a user-friendly surveillance system at home compared to currently provided hospital care for the same indication

Self-management at home in combination with telemedicine in high-risk pregnancies is non-inferior compared to hospital admission regarding safety, cost-effectiveness and patient satisfaction.

inclusion 18 months

Randomisation will take place between traditional hospital admittance or telemonitoring for daily monitoring of maternal and fetal parameters. In telemonitoring pregnant women will make use of a wireless cardiotocograph registration device and home blood pressure monitor and will have daily telephone calls with an obstetric health care professional in the hospital. Weekly outpatient visits will be planned for real-time contact and ultrasound assessment, blood sampling or urinary analysis if necessary.