Design of the P regnancy RE mote MO nitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote
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(2020) 20:626
STUDY PROTOCOL
Open Access
Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders Dorien Lanssens1,2,3* , Inge M. Thijs1,3, Wilfried Gyselaers2,3 and PREMOM II – consortium Abstract Background: Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results. Methods: After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge–Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients’ electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcarerelated costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires. (Continued on next page)
* Correspondence: [email protected] 1 Ziekenhuis Oost-Limburg, Future Health Department, Limburg Clinical Research Center/Mobile Health Unit, Genk, Belgium 2 Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made
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