Mothers Working to Prevent Early Stillbirth Study 20-28

NCT06005272 | Recruiting

• 1 other identifier: 314658
• Study Type: observational
• Target: 948
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perinatal Death; Stillbirth and Fetal Death

Outcome Measures

Primary Outcomes (3)

• Maternal sleep position during pregnancy

  Self-reported sleep position

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

• Duration of sleep during pregnancy

  Self-reported duration of sleep

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

• Presence of snoring during pregnancy

  Self-reported presence of snoring during pregnancy

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

Secondary Outcomes (5)

• Maternal perception of fetal movement frequency

  Two-weeks prior to questionnaire or two weeks prior to pregnancy loss

• Maternal perception of fetal movement strength

  Two-weeks prior to questionnaire or two weeks prior to pregnancy loss

• Maternal caffeine exposure

  One month prior to questionnaire

• Engagement with antenatal care

  Duration of Pregnancy (from booking to the time interview)

• Exposure to Intimate Partner Violence

  Duration of Pregnancy (from booking to the time interview)

Study Arms (2)

Cases

Recently pregnant women/people who have experienced baby loss during pregnancy, labour or shortly after birth between 20-28 weeks of pregnancy

Other: Questionnaire

Controls

Individuals still pregnant at same gestational age

Other: Questionnaire

Interventions

Questionnaire OTHER

Interviewer assisted completion of questionnaire.

Cases; Controls

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

Cases * 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 Controls * 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 * Baby has no evidence of congenital anomaly * Able to give written informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Manchester: lead
• University of Birmingham: collaborator
• University of Leicester: collaborator
• University of Leeds: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Related Publications (1)

• Heazell AE, Wilkinson J, Morris RK, Simpson N, Smith LK, Stacey T, Storey C, Higgins L. Mothers working to prevent early stillbirth study (MiNESS 20-28): a case-control study protocol. BMJ Open. 2024 Jan 18;14(1):e082835. doi: 10.1136/bmjopen-2023-082835.

  PMID: 38238057 DERIVED

MeSH Terms

Conditions

Stillbirth; Fetal Death; Perinatal Death

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Alexander E Heazell, PhD

CONTACT

+441612646484; alexander.heazell@manchester.ac.uk

Lucy Higgins, PhD

CONTACT

lucy.higgins@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

GB (1)