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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Lucy
Higgins
Lucy.higgins@mft.nhs.uk
Dr
Lucy
Higgins
lucy.higgins@manchester.ac.uk
Other disorders originating in the perinatal period
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
For all participants: I. Presence of a known significant congenital anomaly (as informed by the NHS Fetal Anomaly Screening Programme (33)). Control participants who give birth to liveborn baby with a significant congenital anomaly after participation will be excluded from data analysis II. Multifetal pregnancy III. Inability to give consent despite provision of translation services as required IV. Participant age < 16 years v. Individuals not receiving care through a participating hospital Case participants only I. Where signs of life were DETECTED after birth, attempted transfer of the infant to neonatal services Resuscitation attempts are NOT an exclusion if NO ATTEMPT TO TRANSFER TO NEONATAL SERVICES was made. Control participants only: I. Stillbirth/immediate neonatal death after interview (data will be excluded from analysis). Individuals approached to participate as control participants who experience early stillbirth within the 20-28 week gestation bracket BEFORE interview will be invited to participate as case participants instead. Control participants who experience early or late stillbirth after interview will not be re-interviewed.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 57316
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