Evidence map›Paper›PMID 35395741›Full record

ArticleBMC pregnancy and childbirth2022

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.

Valerie Stålberg, Barbro Krevers, Lovisa Lingetun, Therese Eriksson, Ann Josefsson, Caroline Lilliecreutz

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 48% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Valerie StålbergDepartment of Obstetrics and Gynecology, Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, 581 85, Linköping, Sweden. Valerie.stalberg@regionostergotland.se.ORCID http://orcid.org/0000-0003-1345-5437
Barbro KreversDepartment of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Lovisa LingetunDepartment of Obstetrics and Gynecology, Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, 581 85, Linköping, Sweden.
Therese ErikssonDepartment of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Ann JosefssonDepartment of Obstetrics and Gynecology, Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, 581 85, Linköping, Sweden.
Caroline LilliecreutzDepartment of Obstetrics and Gynecology, Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, 581 85, Linköping, Sweden.
Linköping University · SE

Funding

Region Östergötland (SE) ALF GrantsRegion Östergötland (SE) FORSS grants
6 · The paper itself

Abstract

backgroundIt 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.

methodsThis 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.

trial registrationThe study is registered the 21th of April 2021 in the ISRCTN registry with trial ID: ISRCTN14422582 , retrospectively registered.

Indexed as

COVID-19Prenatal CareEquivalence Trials as TopicFemaleHumansInfant, NewbornPandemicsParturitionPregnancyPregnant PeopleRandomized Controlled Trials as TopicAntenatal careCaregiver satisfactione-healthHealth economicsLow risk pregnancyMaternal outcomesNeonatal outcomesPatient satisfactionRisk assessmentVirtual care

Identifiers

PMID35395741
PMCPMC8990275
OpenAlexW4223545868

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.