Pregnancy Risk Flagging System Phase 2: satisfactio

Recruiting

Conditions: not applicable

Registration Number: NL-OMON20682

Lead Sponsor: Philips Experience Design

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 164

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

•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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br>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. <br>In addition, a retrospective analysis of the risk flagging functionality by the PRFS will be conducted. <br>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.