Status:
ENROLLING_BY_INVITATION
Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care
Lead Sponsor:
UMC Utrecht
Conditions:
Telemedicine
Digital Health
Eligibility:
FEMALE
18+ years
Brief Summary
Pregnancy care is under increasing pressure due to a rising number of women needing medical care, a shortage of obstetric healthcare professionals, and growing healthcare costs. For women with high-ri...
Detailed Description
This study investigates the implementation and effectiveness of telemonitoring using cardiotocography (CTG) and blood pressure (BP) home monitoring in four European academic hospitals. RDPC allows pre...
Eligibility Criteria
Inclusion
- ≥18 years old
- A singleton pregnancy of ≥26+0 weeks of gestation (UMCU, EMC, and Vall d'Hebron) or ≥24+0 weeks of gestation (Karolinska)
- Able to give informed consent.
- Proficiency in English or the local language (Dutch, Spanish or Swedish)
- The presence of a complication requiring CTG monitoring according to local protocol
Exclusion
- Pregnancy complications requiring intravenous (IV) anti-hypertensive therapy
- Expected obstetric intervention within 48 hours
- Current blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic
- Active antepartum hemorrhage
- CTG abnormalities suggestive of fetal stress or hypoxia
- Residence located more than a 30-minute drive from any hospital (not necessarily the hospital initiating home monitoring)
- Presence of an implanted medical device (e.g. pacemaker)
Key Trial Info
Start Date :
February 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT07191236
Start Date
February 17 2025
End Date
February 29 2028
Last Update
September 24 2025
Active Locations (4)
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1
Erasmus Medical Center Rotterdam (EMC)
Rotterdam, South Holland, Netherlands, 3015 GD
2
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands, 3584 CX
3
Catalan health institute: Vall d'Hebron University Hospital & Vall d'Hebron Research Institute (VHIR)
Barcelona, Catalonia, Spain, 08035
4
Region Stockholm: Karolinska Institutet
Stockholm, Stockholm County, Sweden, 17177