- Design
- Multicentre, unblinded, non-inferiority randomised trial
- Population
- 270 pregnant women at high risk of pre-eclampsia in Australia
- Primary outcome
- Composite of perinatal loss, >48 h high-level neonatal care or small-for-gestational-age baby
- Effect
- HR 1.0 (0.57 to 1.76); any admission HR 0.54 (0.30 to 0.97)
This unblinded non-inferiority trial, published in April 2026, randomised 270 women at high risk of pre-eclampsia across three Australian hospitals. All received routine antenatal care. The control group attended a specialist hypertension clinic in person; the intervention group measured their own blood pressure with an automated device that sent results through a smartphone app for specialist review.
The composite perinatal outcome of loss, more than 48 hours of high-level neonatal care or a small-for-gestational-age baby was no different (HR 1.0, 95% CI 0.57 to 1.76). Women monitoring at home had fewer antenatal attendances (median 14 vs 16) and fewer planned outpatient visits (10 vs 13), with no rise in unscheduled presentations. They were less likely to be admitted for any cause (HR 0.54, 0.30 to 0.97) and for hypertension (HR 0.41, 0.19 to 0.88), and filled more antihypertensive prescriptions.
For services stretched by extra blood pressure visits, this supports moving part of that surveillance home, provided a clinician reviews the readings and acts on them. The wide interval around the primary outcome means rare serious harms cannot be excluded, and the model depends on a responsive specialist team rather than the device alone. In India, where travel to a tertiary clinic can cost a woman a day's work, the approach is attractive, but it has not been tested here.
- Consider offering home blood pressure monitoring with clinician review to women at high risk of pre-eclampsia.
- Set up a named team and a response time for reviewing transmitted readings before starting.
- Keep routine antenatal visits; the trial replaced specialist hypertension visits, not standard care.
- Expect more antihypertensive prescribing when readings are seen more often.
- Audit admissions and perinatal outcomes locally if you adopt it.
Why it matters
Extra surveillance in high-risk pregnancy does not have to mean extra trips to clinic.
Don't overread it
The trial was not large enough to rule out rare serious harms, and it tested a reviewed service, not a device on its own.
The statistics, in plain English
A hazard ratio of 1.0 with an interval from 0.57 to 1.76 means no difference was seen, but the data are compatible with anything from substantial benefit to substantial harm. The fall in admissions is a secondary outcome, so it supports the main finding rather than standing as proof on its own.
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