MiNESS 20-28
Research type
Research Study
Full title
Mothers working to prevent early stillbirth study: MiNESS 20-28
IRAS ID
314658
Contact name
Lucy Higgins
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
The United Kingdom has one of the highest rates of stillbirth in Europe, with more than 4,000 stillbirths every year (more than 11 deaths every day). A 15% reduction in stillbirths has been achieved by identifying and providing appropriate care to individuals at highest risk of stillbirth after 28 weeks' gestation. However, around 1,600 babies are stillborn each year between 20-28 weeks of pregnancy. This number has not changed in recent years, partly because of lack of understanding of which babies are most at risk and what can be done to prevent their death. This urgently needs addressing.
We conducted the Midlands and North of England Stillbirth Study (MiNESS) investigating modifiable factors associated with stillbirth and found that mothers who went to sleep on their back, or who consumed more than recommended amounts of caffeine had a two-fold increased risk of late stillbirth (≥28 weeks gestation) compared to mothers who did not. Whether these are also related to early stillbirth is unknown.
This proposed study aims to use the same methodology to confirm or refute these findings (and identify novel factors) in relation to early (20-28 weeks) stillbirth, and ascertain whether a preventative programme should be introduced. Participants will be recruited from maternity units in the Midlands and North of England (led by centres in Manchester, West Yorkshire and Birmingham). 316 bereaved mothers/parents with a singleton early stillbirth without congenital abnormality will be interviewed by research midwives shortly after the birth. A control group of 632 women/people with ongoing pregnancies will be interviewed at a gestation matched to that at which early stillbirths occurred.
These data will determine whether an intervention study should be considered. If maternal sleep position, or other modifiable factor, and early stillbirth are similarly causally related we estimate that up to 37% of early stillbirths might be prevented.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0622
Date of REC Opinion
17 Jul 2023
REC opinion
Favourable Opinion