Abstract
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
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 language | English |
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Journal | BMJ Open |
Publication status | Accepted/In press - 13 Dec 2023 |
Keywords
- Early stillbirth
- Baby loss
- Late miscarriage
- Neonatal death
- Pregnancy loss
- Preterm birth
- Perinatal death
- Case control study
- Risk factors
- Sleep position