Mothers working to prevent early stillbirth study (MiNESS 20-28): Case Control Study Protocol

A. E. P. Heazell, J. D. Wilkinson, R. K. Morris, N. A. B. Simpson, L. Smith, T. Stacey , C. Storey, L. E. Higgins

Research output: Contribution to journalArticlepeer-review


Introduction: In the UK 1,600 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 wellbeing 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 20-28 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 – 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 odds ratios 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). 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 health care professionals and pregnant people to reduce risk of early stillbirth.

Trial registration: NCT06005272
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 13 Dec 2023


  • Early stillbirth
  • Baby loss
  • Late miscarriage
  • Neonatal death
  • Pregnancy loss
  • Preterm birth
  • Perinatal death
  • Case control study
  • Risk factors
  • Sleep position


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