About this trial
This project aims to identify factors linked to pregnancy losses occurring between 20 and 28 weeks of pregnancy that can be modified by changing mother's behaviour or healthcare provision.
The death of a child before birth (also called stillbirth or miscarriage) has enduring psychological, social and economic effects for women, their families and wider society. In 2015, the stillbirth rate in the UK was higher than comparable countries. The UK government has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year.
Identification of modifiable causes of stillbirth was identified as a research priority by the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third of whom were bereaved parents. The investigators previously completed a study of 291 women who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in 41 maternity units in the UK. This study identified factors linked to stillbirth which can be changed including the position women go to sleep in, cigarette smoking and caffeine consumption. In addition, the investigators previously found changes in mother's perception of baby's movements, whether women had tests for diabetes or whether women were exposed to domestic violence or stressful situations. These factors can be addressed by different care in pregnancy. Information from this study has been included in national and international guidelines that aim to reduce stillbirth.
The investigators will use the same study type to identify factors associated with pregnancy loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked parents who have experienced the death of a baby at these stages of pregnancy about the design of the study, the questions that would be asked and how best to approach bereaved parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not usually "counted" in UK stillbirth statistics. The investigators will need 316 women with stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy to participate in the study. All women will complete a questionnaire about themselves, their diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will compare information between women who have early stillbirth and those who have a live birth to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study findings will be disseminated in collaboration with patient organisations using effective ways to reach pregnant women. The investigators anticipate the findings from this study will be included in clinical practice guidelines and rapidly translated into antenatal care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Bereaved mothers/parents who have recently birthed a singleton baby who died before/during or immediately after labour between 20 and 28 weeks of pregnancy.
Baby has no evidence of congenital anomaly
Able to give written informed consent
Pregnant women/people with an ongoing pregnancy (at the target gestation) receiving antenatal care from a participating maternity unit, at a gestation matched to the distribution of stillbirths between 20 to 28 weeks of pregnancy in the same unit
Disqualifiers
None
Trial population
Women who have experienced an early stillbirth and women who have an ongoing pregnancy at gestations matched to the profile of women who experienced an early stillbirth from participating maternity units in the UK.
Trial design
Case-control
Prospective
Treatments tested in this trial
Questionnaire
Other interventionInterviewer assisted completion of questionnaire.
Treatment groups
Trial outcomes
Primary outcomes
Maternal sleep position during pregnancy
Self-reported sleep position
Duration of sleep during pregnancy
Self-reported duration of sleep
Presence of snoring during pregnancy
Self-reported presence of snoring during pregnancy
Secondary outcomes
Maternal perception of fetal movement frequency
Self-reported perception of frequency of fetal activity
Maternal perception of fetal movement strength
Self-reported perception of strength of fetal activity
Maternal caffeine exposure
Self-reported intake of caffeinated drinks
Engagement with antenatal care
Number of appointments with health professionals
Sponsors and contacts
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University of Manchester
Lead sponsor
University of Birmingham
Collaborator
University of Leicester
Collaborator
University of Leeds
Collaborator