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TRIUMPH study

Time-in-Range and Its Use in Monitoring Pregnancies with Hypertension - TRIUMPH study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57485
Enrollment
350
Registered
2025-02-25
Start date
2025-06-13
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension during pregnancy

Interventions

Blood pressure measurements from Luscii platform.&nbsp

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: Pregnant women = 16 years diagnosed with pre-existing hypertension.Availability of Luscii HBPM data during pregnancy.Delivery data available (discharge summary).

Exclusion criteria

Exclusion criteria: Objection against the use of data for research purposes.

Design outcomes

Primary

MeasureTime frame
Time-in-range blood pressure, defined as the number of days and percentage of total measurements that blood pressure was within range (systolic < 140 mmHg, diastolic <90 mmHg). The main outcome of interest is incidence of preeclampsia superimposed on pre-existing hypertension, defined as development or proteinuria (>300 mg/24 hr), fetal growth restriction or maternal organ damage after 20 weeks gestational age, as defined in the latest guideline .

Secondary

MeasureTime frame
Secondary outcomes include gestational age at birth and neonatal birthweight.  As a secondary analysis, we will assess if a stricter range (e.g., <130/80 mmHg or even 120/70) is associated with a lower incidence of outcomes. 

Countries

Netherlands

Contacts

Public ContactK. Verdonk

Erasmus MC, Universitair Medisch Centrum Rotterdam

k.verdonk@erasmusmc.nl010-7040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)