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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51019

Enrollment

164

Registered

2020-12-22

Start date

2021-03-15

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

(Vulnerable) pregnancy

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria: · Anomalous findings of foetus at the 20 weeks ultrasound scan

Design outcomes

Primary

Measure	Time frame
The primary outcome is a 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

Measure	Time 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 PRFS risk flagging functionality will be conducted. Finally, an analysis on satisfaction and user experience for a subgroup of vulnerable women (retrospectively identified by using the R4U questionnaire) versus not-vulnerable women will be performed. This will also be done for the women in primary care only, in secondary care only and referred during pregnancy.	—

Measure

Time 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 PRFS risk flagging functionality will be conducted. Finally, an analysis on satisfaction and user experience for a subgroup of vulnerable women (retrospectively identified by using the R4U questionnaire) versus not-vulnerable women will be performed. This will also be done for the women in primary care only, in secondary care only and referred during pregnancy.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)