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Pregnancy Risk Flagging System Phase 2: satisfaction

Improving Care of Pregnant Women in the Netherlands by early identification of Perinatal & Maternal Risks. Pregnancy Risk Flagging System Phase 2: satisfaction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20682
Enrollment
164
Registered
2020-09-02
Start date
2020-11-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

None listed

Interventions

Use of app to report their pregnancy symptoms in addition to the regular antenatal care by pregnant women. During the antenatal care visit (ANC visit), the HCP has access to a symptoms-overview of th

Sponsors

Philips Experience Design
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Pregnant women with a viable and non-anomalous foetus at the 20 weeks anomaly scan • 18 years or older • Able to read and understand English and/or Dutch language (we are aware this could lead to selection bias but in this phase of the experiment, questionnaires will only be available in English and Dutch) • Have smartphone and internet access iPhone: at least iPhone 7, running the latest iOS version that is on the market at the date of starting the study Android: not older than 5 years old phone running at least Android 6.0 • Willing and able to provide informed consent (IC)

Exclusion criteria

Exclusion criteria: • Anomalous foetus at the 20 weeks ultrasound • In case the pregnant woman continues her ANC visits before 35-37 weeks of gestation in another hospital other than Máxima MC or another midwifery practice other than PUUR or 040 Verloskunde (because HCPs at other centres do not have access to the PRFS dashboard prototype, and the pregnant women did not receive the PCQ and SUS questionnaires at that time yet) • Delivery before the second questionnaire measurement at 35-37 weeks of gestation • Perinatal death

Design outcomes

Primary

MeasureTime frame
Comparison of patient satisfaction between the intervention and control group, measured at 18-22 weeks of gestation (baseline) and at 35-37 weeks of gestation using the Pregnancy and Childbirth Questionnaire (PCQ).

Secondary

MeasureTime frame
Secondary parameters include an exploration of the usability and user experience, measured by means of customized quantitative and qualitative questions as well as the System Usability Scale (SUS), for the pregnant women in the intervention group at 28-29 and 35-37 weeks of gestation and for HCPs using the basic dashboard to be sent out 4 months after the start of the study and at the end of the study. In addition, a retrospective analysis of the risk flagging functionality by the PRFS will be conducted. Finally, a satisfaction and user experience for a subgroup of vulnerable women* (*retrospectively identified by using the R4U questionnaire) versus not-vulnerable women will be determined.

Contacts

Public ContactChantelle de Vet

Máxima Medisch Centrum

chantelle.de.vet@mmc.nl0627152097

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)