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

Recruiting

Conditions: (Vulnerable) pregnancy
10026908

Registration Number: NL-OMON51019

Lead Sponsor: Philips Electronics Nederland B.V.

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 pregnancy
· 18 years or older
· Able to read and understand English and/or Dutch language
· Have smartphone and internet access
o iPhone: at least iPhone 7, running the latest iOS version that is on the
market at the date of
starting the study
o Android: not older than 5 years old phone running at least Android 6.0
· Willing and able to provide informed consent
· Woman expects to be available during entire study follow-up (meaning, she has
no plans to travel or move in near future during her pregnancy)

Exclusion Criteria

· Anomalous findings of foetus at the 20 weeks ultrasound scan

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is a comparison of patient satisfaction between the<br /><br>intervention and control group, measured at 18-22 weeks of gestation (baseline)<br /><br>and at 35-37 weeks of gestation using the Pregnancy and Childbirth<br /><br>Questionnaire (PCQ). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters include an exploration of the usability and user<br /><br>experience, measured by means of customized quantitative and qualitative<br /><br>questions as well as the System Usability Scale (SUS), for the pregnant women<br /><br>in the intervention group at 28-29 and 35-37 weeks of gestation and for HCPs<br /><br>using the basic dashboard to be sent out 4 months after the start of the<br /><br>study and at the end of the study.<br /><br>In addition, a retrospective analysis of the PRFS risk flagging functionality<br /><br>will be conducted.<br /><br>Finally, an analysis on satisfaction and user experience for a subgroup of<br /><br>vulnerable women (retrospectively identified by using the R4U questionnaire)<br /><br>versus not-vulnerable women will be performed. This will also be done for the<br /><br>women in primary care only, in secondary care only and referred during<br /><br>pregnancy. </p><br>