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

Pregnancies with an increased risk of maternal or fetal complications often
require long-term hospital admission. Innovative use of portable and wireless
cardiotocography and blood pressure devices can be used for telemonitoring of
high risk pregnancies. There are a number of advantages of telemonitoring for
patients, health care providers, and insurance companies. In consultation with
her own doctor or midwife, the high risk pregnancy patient will have more
autonomy over her time and she will receive more feedback about vital
functions.

To test telemonitoring with wireless CTG and blood pressure devices as a novel
obstetric care strategy compared to hospital admittance in high risk
pregnancies who require daily monitoring. Primary outcome is safety of
pregnancy outcome measured by perinatal mortality and morbidity. Secondary
objectives are patient satisfaction, quality of life and cost effectiveness.

Multicentre randomized controlled clinical trial; non-inferiority

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 the Sense4Baby CTG registration
device and Microlife 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.

Structural risk analysis is associated with moderate risk for randomized
patients.
Patients can only be randomised when they meet strict inclusion criteria on
knowledge of Dutch or English language and the understanding of the devices.
Patients will be clearly instructed to perform measurement with all devices.
They can make contact with health care professionals 24 hours per day if any
physical complaints or questions arise. They should always get in touch before
they perform measurement outside their treatment plan. If the patient does not
understand the devices or the treatment plan, telemonitoring can be changed
into clinical admission. These measures have proven our telemonitoring strategy
before to be very effective, safe and patient friendly. In our hospital we
already work with the devices for telemonitoring since 2014 and during these
years no adverse advents occurred. This study however is powered on safety and
we should therefor be careful not to take any conclusion too fast.
Possible risks include deterioration of maternal or fetal condition at home,
e.g. rise in hypertension, physical complaints, non-reassuring CTG. These
symptoms should be reported to the midwife or doctor in time to evaluate the
condition in the hospital. If there is a patient delay or doctor*s delay (for
example when the non-reassuring CTG has not been reviewed in time) quick
transportation to the hospital may be needed, possibly with ambulance and
paramedical help. Stablisation of hypertension with intravenous medication in
clinical setting and induction of labour of caesarean section may be needed.
However, this clinical decline cannot be prevented and can happen on ward as
well as at home.
Possible benefits include the possibility to stay at home with all of its
advantages. Women with experience in pregnancy telemonitoring reported relief
about sleeping at home, better food, seeing partners and first child(s) more
often and good feeling of security with at home monitoring and weekly
face-to-face visits. Main possible societal benefit is cost reduction of less
clinical admissions of expensive ward beds while a considarable amounts of time
is saved with measurements being done by the patient herself.