Complicated pregnancies often require hospital admission, which can be stressful and inconvenient for expectant mothers. Telemonitoring, the remote monitoring of patients using technology, has emerged as a promising alternative to traditional hospital care. It not only fulfils a worldwide need in obstetric healthcare but has also been accelerated by the COVID-19 pandemic.
A recent study conducted in the Netherlands aimed to evaluate the safety, clinical effectiveness, patient satisfaction, and costs of home telemonitoring against hospital care in complicated pregnancies.
The multicentre, randomised, controlled, non-inferiority trial was conducted in six hospitals, including four general teaching hospitals and two university hospitals. Participants included women aged 18 years and older with singleton pregnancies (>26 weeks gestation) requiring monitoring for pre-eclampsia, fatal growth restriction, foetal anomaly, preterm rupture of membranes, reduced foetal movements, or history of fatal death.
The study, which was registered at the Dutch Trial Registration (NL5888), enrolled 201 pregnant women from Dec 1, 2016, to Nov 30, 2019. Of these, 101 women were allocated to the telemonitoring group and 100 to the hospital admission group. One participant in the telemonitoring group withdrew consent before the intervention was initiated, and 100 participants were analysed for the primary outcome. In the hospital admission group, four participants did not receive the allocated intervention because they did not accept hospital admission. 100 participants in each group were analysed for the primary outcome according to the intention-to-treat principal. No participants were lost to follow-up.
Participants were randomly assigned to either hospital admission or telemonitoring in a 1:1 ratio, stratified for the six diagnoses for inclusion and the six centres of inclusion, using block randomisation (block sizes of four and six). When assigned to telemonitoring, participants went home with devices for cardiotocography and blood pressure measurements and had daily contact with their care providers after digitally sending their home measurements. When assigned to hospital admission, participants received care as usual on the ward until their postpartum period.
The primary outcome was a composite of adverse perinatal outcomes assessed after delivery, including mortality, an Apgar score below 7 after 5 min or an umbilical arterial pH at birth below 7·05, maternal morbidity, admission of the new-born to the neonatal intensive care unit, and rate of caesarean section. It was assessed in the intention-to-treat population. The non-inferiority margin for the primary outcome was a 10% absolute increase in composite primary endpoint based on baseline 20% incidence.
The primary outcome occurred in 31 (31%) of 100 participants in the telemonitoring group and in 40 (40%) of 100 participants in the hospital admission group. Adjusted for centre of inclusion, diagnosis, and nulliparity, the risk difference in primary outcome between both groups was 10·3% (95% CI –22·4 to 2·2) lower in the telemonitoring group, below the pre-defined non-inferiority margin of 10% absolute increase. A similar distribution for each of the individual components within the composite primary outcome was seen between groups.
Five serious adverse events were reported, including one neonatal death in the hospital admission group, in addition to one intra-uterine foetal death, two neonatal deaths, and one case of eclampsia in the telemonitoring group, all unrelated to the study.
This study provides important evidence to support the implementation of telemonitoring as a safe and effective alternative to hospital care for pregnant women with complicated pregnancies, which can help reduce the burden on healthcare resources and increase patient satisfaction.