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Study protocol for a modified antenatal care program for pregnant women with a low risk for adverse outcomes - a stepped wedge cluster non-inferiority randomized trial
Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.ORCID iD: 0000-0003-3678-2932
Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.ORCID iD: 0000-0001-6855-6169
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2022 (English)In: BMC Pregnancy and Childbirth, ISSN 1471-2393, E-ISSN 1471-2393, Vol. 22, no 1, article id 999Article in journal (Refereed) Published
Abstract [en]

Background: It is crucial to provide care based on individual needs. Swedish health care is obliged to give care on equal conditions for the entire population. The person with the greatest need should be given the most care, and the health care system should strive to be cost-efficient. Medical and technical advances have been significant during the last decades and the recent Covid-19 pandemic has caused a shift in health care, from in-person visits to virtual visits. The majority of pregnant women with a low risk assessment have an uncomplicated antenatal course without adverse events. These women probably receive excessive and unnecessary antenatal care. This study will investigate if an antenatal care program for healthy pregnant women with a low risk for adverse outcomes could be safely monitored with fewer in-person visits to a midwife, and with some of them replaced by virtual visits.

Methods: This is a non-inferiority trial where a stepped wedge cluster randomized controlled design will be used. Data collection includes register data and questionnaires that concern antenatal, obstetric and neonatal outcomes, patient- and caregiver-reported experiences, healthcare-economy, and implementation aspects. The modified antenatal care (MAC) study is performed in parts of the southeast of Sweden, which has approximately 8200 childbirths annually. At the start of the study, all antenatal care centers included in the study will use the same standard antenatal care (SAC) program. In the MAC program the in-person visits to a midwife will be reduced to four instead of eight, with two additional virtual meetings compared with the SAC program.

Discussion: This presented study protocol is informed by research knowledge. The protocol is expected to provide a good structure for future studies on changed antenatal care programs that introduce virtual visits for healthy pregnant women with a low risk for adverse outcomes, without risking quality, safety, and increased costs.

Place, publisher, year, edition, pages
London, United Kingdom: BioMed Central, 2022. Vol. 22, no 1, article id 999
Keywords [en]
Antenatal care; Risk assessment; Low risk pregnancy; Maternal outcomes; Neonatal outcomes; Virtual care; Patient satisfaction; Caregiver satisfaction; Health economics; e-health
National Category
Nursing
Identifiers
URN: urn:nbn:se:liu:diva-184559DOI: 10.1186/s12884-022-04406-7ISI: 000779606500003PubMedID: 35395741Scopus ID: 2-s2.0-85127637021OAI: oai:DiVA.org:liu-184559DiVA, id: diva2:1655784
Note

Funding Agencies: county council of Östergötland, Sweden; Medical Research Council of Southeast Sweden (FORSS); Linköping University; ALF

Available from: 2022-05-03 Created: 2022-05-03 Last updated: 2022-05-30Bibliographically approved

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Krevers, BarbroEriksson, ThereseJosefsson, AnnLilliecreutz, Caroline

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Stålberg, ValerieKrevers, BarbroLingetun, LovisaEriksson, ThereseJosefsson, AnnLilliecreutz, Caroline
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Division of Children's and Women's HealthFaculty of Medicine and Health SciencesDepartment of Gynaecology and Obstetrics in LinköpingDivision of Society and Health
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