Heazell, A.E. orcid.org/0000-0002-4303-7845, Wilkinson, J. orcid.org/0000-0003-3513-4677, Morris, R.K. et al. (5 more authors) (2024) Mothers working to prevent early stillbirth study (MiNESS 20–28): a case–control study protocol. BMJ Open, 14 (1). e082835. ISSN 2044-6055
Abstract
Introduction In the UK, 1600 babies die every year before, during or immediately after birth at 20–28 weeks’ gestation. This bereavement has a similar impact on parental physical and psychological well-being to late stillbirth (>28 weeks’ gestation). Improved understanding of potentially modifiable risk factors for late stillbirth (including supine going-to-sleep position) has influenced international clinical practice. Information is now urgently required to similarly inform clinical practice and aid decision-making by expectant mothers/parents, addressing inequalities in pregnancy loss between 20 and 28 weeks.
Methods and analysis This study focuses on what portion of risk of pregnancy loss 20–28 weeks’ gestation is associated with exposures amenable to public health campaigns/antenatal care adaptation. A case–control study of non-anomalous singleton baby loss (via miscarriage, stillbirth or early neonatal death) 20+0 to 27+6 (n=316) and randomly selected control pregnancies (2:1 ratio; n=632) at group-matched gestations will be conducted. Data is collected via participant recall (researcher-administered questionnaire) and extraction from contemporaneous medical records. Unadjusted/confounder-adjusted ORs will be calculated. Exposures associated with early stillbirth at OR≥1.5 will be detectable (p<0.05, β>0.80) assuming exposure prevalence of 30%–60%.
Ethics and dissemination NHS research ethical approval has been obtained from the London—Seasonal research ethics committee (23/LO/0622). The results will be presented at international conferences and published in peer-reviewed open-access journals. Information from this study will enable development of antenatal care and education for healthcare professionals and pregnant people to reduce risk of early stillbirth.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
Keywords: | Humans; Abortion, Spontaneous; Prenatal Care; Case-Control Studies; Mothers; Pregnancy; Infant, Newborn; Female; Stillbirth; Surveys and Questionnaires |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Medical Research (LIMR) > Division of Pathology and Data Analytics |
Depositing User: | Symplectic Publications |
Date Deposited: | 07 Feb 2024 14:06 |
Last Modified: | 07 Feb 2024 14:06 |
Published Version: | http://dx.doi.org/10.1136/bmjopen-2023-082835 |
Status: | Published |
Publisher: | BMJ |
Identification Number: | 10.1136/bmjopen-2023-082835 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:208836 |