Evidence map›Paper›PMID 37996235›Full record

ArticleBMJ open2023

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis.

Kathryn Willan, Rachael H Moss, Gillian Santorelli, Sara Ahern, Maria Bryant, Tracey Bywater, Sarah Louise Blower, Gerry Richardson, Sebastian Hinde, Dacheng Huo and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
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

13 authors at 2 institutions in 1 country.

Kathryn WillanBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK.
Rachael H MossBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK.ORCID 0000-0002-3015-7768
Gillian SantorelliBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK.
Sara AhernBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK.
Maria BryantHealth Sciences, University of York, York, North Yorkshire, UK.
Tracey BywaterHealth Sciences, University of York, York, North Yorkshire, UK.
Sarah Louise BlowerHealth Sciences, University of York, York, North Yorkshire, UK.ORCID 0000-0002-9168-9995
Gerry RichardsonCentre for Health Economics, University of York, York, North Yorkshire, UK.
Sebastian HindeCentre for Health Economics, University of York, York, North Yorkshire, UK.ORCID 0000-0002-7117-4142
Dacheng HuoCentre for Health Economics, University of York, York, North Yorkshire, UK.
John WrightBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK.ORCID 0000-0001-9572-7293
Josie DickersonBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK Josie.Dickerson@bthft.nhs.uk.ORCID 0000-0003-0121-3406
Better Start Bradford Innovation HubBradford Teaching Hospitals NHS Foundation Trust, Bradford, Bradford, UK.
Bradford Teaching Hospitals NHS Foundation Trust · GBUniversity of York · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWomen from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population. METHODS AND ANALYSIS: An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives. ETHICS AND DISSEMINATION: Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings. TRIAL REGISTRATION NUMBER: IsRCTNhttps://doi.org/10.1186/ISRCTN31836167.

Indexed as

MidwiferyContinuity of Patient CareFemaleHumansMaternal HealthMental HealthPragmatic Clinical Trials as TopicPregnancyProspective StudiesRandomized Controlled Trials as TopicMaternal medicineMENTAL HEALTHPUBLIC HEALTH

Identifiers

PMID37996235
PMCPMC10668235
OpenAlexW4388947820

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.