Mothers Working to Prevent Early Stillbirth Study 20-28

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16-50
SponsorUniversity of Manchester

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire

    Other intervention

    Interviewer assisted completion of questionnaire.

Treatment groups

948 Participants
are divided into 2 treatment groups
Group A: Cases1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

Maternal sleep position during pregnancy

Self-reported sleep position

Time frame
The night prior to questionnaire or the night prior to pregnancy loss
2

Duration of sleep during pregnancy

Self-reported duration of sleep

Time frame
The night prior to questionnaire or the night prior to pregnancy loss
3

Presence of snoring during pregnancy

Self-reported presence of snoring during pregnancy

Time frame
The night prior to questionnaire or the night prior to pregnancy loss

Secondary outcomes

1

Maternal perception of fetal movement frequency

Self-reported perception of frequency of fetal activity

Time frame
Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
2

Maternal perception of fetal movement strength

Self-reported perception of strength of fetal activity

Time frame
Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
3

Maternal caffeine exposure

Self-reported intake of caffeinated drinks

Time frame
One month prior to questionnaire
4

Engagement with antenatal care

Number of appointments with health professionals

Time frame
Duration of Pregnancy (from booking to the time interview)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manchester

Lead sponsor

University of Birmingham

Collaborator

University of Leicester

Collaborator

University of Leeds

Collaborator