Pregnancy Risk Flagging System Phase 2: satisfaction

Rationale: Pregnant women seem to find it hard to distinguish physiological changes during pregnancy from pathological symptoms indicating a potential pregnancy complication. Early detection of a pregnancy complication may prevent or decrease the risk of adverse maternal and neonatal outcomes. Vulnerable women are particularly at risk of adverse perinatal due to multiple factors. There is a need to provide pregnant women with reliable information and advice regarding physiological and pathological symptoms and when to contact a healthcare professional (HCP).

We have developed a prototype for real time patient monitoring of pregnant women, as RPM (remote patient monitoring) is still lacking in the area of antenatal care. The Pregnancy Risk Flagging System (PRFS) consists of a mobile application (app) called for pregnant women to self-report symptoms and parameters as blood pressure and foetal kick count.

Leveraging this technology for antenatal care could contribute to higher patient satisfaction by enabling increased personal care and by assisting earlier identification of potential pregnancy risks because of real time monitoring. This, in turn, could have the potential to improve maternal and neonatal outcomes. Specifically, vulnerable pregnant women could benefit from this technology as they make suboptimal use of the current healthcare system. However, in order to implement this system in daily practice, user experience and risk flagging functionality must be examined first.

Objective: To assess patient satisfaction of antenatal care perceived by (vulnerable) pregnant women and explore the user experience by (vulnerable) pregnant women and HCPs (healthcare professionals working in antenatal care) while using the app for real time symptom reporting, in addition to regular antenatal care. Furthermore, the risk flagging functionality of this system will be examined retrospectively.

Study design: Multicenter, randomized controlled trial.

Population: 164 pregnant women recruited at 18-22 weeks of pregnancy (after the 20 weeks ultrasound scan until 6 weeks postpartum. Pregnant women will be recruited from 3 sites in The Netherlands to achieve sample size: one hospital (Máxima Medical Center Veldhoven, and two primary care midwifery practices: PUUR Verloskundig Centrum Veldhoven and 040 Verloskunde, Eindhoven.

Intervention: 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 the pregnant woman in the PRFS basic dashboard prototype and this will be discussed between the pregnant woman and HCP. The control group of pregnant women will use regular antenatal care.

Main study parameters: 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 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 performed. This will also be done for the women in primary care only, in secondary care only and referred during pregnancy.

We hypothesize that the pregnant women in the intervention group (using the PRFS ) will be more satisfied about the perceived quality of antenatal care than the women in the control group.

Expected start date half of November after ICBE/METC approval
Expected end date: 9 to 12 months after start date

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 the pregnant woman in the PRFS basic dashboard prototype and this will be discussed between the pregnant woman and HCP. The control group of pregnant women will use regular antenatal care.