Stillbirth and Fetal DeathMiNESS20-28NCT06005272
Mothers Working to Prevent Early Stillbirth Study 20-28
An observational study of Stillbirth and Fetal Death and Perinatal Death, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillbirth and Fetal Death, Perinatal Death
- What is being tested?
- Questionnaire
- How many people
- 948 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucy Higgins, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Linda Peacock, RM, 01617016965
About this study
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.
Read more
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.
Read the detailed description
Research question What are the modifiable risk factors for early stillbirth (between 20-28 weeks' gestation)?
Background The NHS Long Term Plan sets a goal to reduce stillbirth by 50% by 2025 (from 2013 rates). Some progress has been made with reduction of stillbirths in late pregnancy (≥28 weeks' gestation). However, rates of early stillbirth (<28 weeks' gestation) remain intractable and new initiatives to reduce early stillbirth rates are needed to achieve this goal. Our previous study (MiNESS) informed about modifiable risk factors for stillbirth ≥28 weeks' gestation and were incorporated into national guidance to reduce stillbirth. However, there is an evidence gap related to modifiable risk factors for early stillbirth.
Aims and Objectives The overall aim of the study is to
- Identify modifiable risk factors for early stillbirth that are amenable to public health campaigns or adaptation of antenatal care. The study will specifically,
- Confirm or refute whether modifiable behavioural factors associated with late stillbirth are also independently associated with early stillbirth.
- Explore interactions between maternal characteristics (especially those relating to health inequalities including ethnicity and socioeconomic deprivation), fetal factors (including fetal growth restriction, reduced fetal movements) and early stillbirth risk.
- Determine differences in risk factor profiles by cause of death.
Methods This study uses a case-control design based upon that successfully used in the MiNESS study. The eligible population are women with a non-anomalous singleton pregnancy. "Cases" are women who have a stillbirth between 20+0 and 27+6 weeks' gestation and "Controls" are women who have an ongoing viable pregnancy at an equivalent gestational age. Controls will be randomly selected from participating maternity units' booking list at the appropriate week of pregnancy to match the unit's historic distribution of early stillbirths in a 1:2 (case:control) ratio. The study will recruit 316 cases and 632 controls; this gives 80% power to detect associations with an odds ratio ≥1.5. Participants will complete a researcher-administered questionnaire and relevant data will be extracted from medical records. Cases will be approached before hospital discharge, aiming to complete the research interview where possible within 3 weeks.
Unadjusted associations between early stillbirth and each exposure will be calculated. Logistic regression models, adjusted for confounding variables, will consider multiple exposures in relation to early stillbirth.
- Conditions
- Stillbirth and Fetal Death, Perinatal Death
- Being tested
- Questionnaire
- Medical subject headings
- Stillbirth, Fetal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Interviewer assisted completion of questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Recently pregnant women/people who have experienced baby loss during pregnancy, labour or shortly after birth between 20-28 weeks of pregnancy Receives: Other: Questionnaire | |
| Controls | Individuals still pregnant at same gestational age Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sleep position during pregnancy
Self-reported sleep position
Measured: The night prior to questionnaire or the night prior to pregnancy loss
Duration of sleep during pregnancy
Self-reported duration of sleep
Measured: The night prior to questionnaire or the night prior to pregnancy loss
Presence of snoring during pregnancy
Self-reported presence of snoring during pregnancy
Measured: The night prior to questionnaire or the night prior to pregnancy loss
Secondary outcomes (5)
Maternal perception of fetal movement frequency
Self-reported perception of frequency of fetal activity
Measured: Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
Maternal perception of fetal movement strength
Self-reported perception of strength of fetal activity
Measured: Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
Maternal caffeine exposure
Self-reported intake of caffeinated drinks
Measured: One month prior to questionnaire
Engagement with antenatal care
Number of appointments with health professionals
Measured: Duration of Pregnancy (from booking to the time interview)
Exposure to Intimate Partner Violence
Self-reported exposure to abusive behaviour using standardised questions
Measured: Duration of Pregnancy (from booking to the time interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stillbirth and Fetal DeathStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 948 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Leicester, University of Leeds
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005272
- Sponsor's protocol ID
- 314658
- Acronym
- MiNESS20-28
- Status last verified
- Feb 2026
- First submitted
- 9 May 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Awaiting clearance from the Health Research Authority to share anonymised data for IPD.
Publications
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.
PubMed 38238057
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers Working to Prevent Early Stillbirth Study 20-28
- ClinicalTrials.gov ID
- NCT06005272
- Acronym / sponsor ID
- MiNESS20-28 / 314658
- Conditions
- Stillbirth and Fetal Death, Perinatal Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 948 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Leicester, University of Leeds
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research question What are the modifiable risk factors for early stillbirth (between 20-28 weeks' gestation)?
Background The NHS Long Term Plan sets a goal to reduce stillbirth by 50% by 2025 (from 2013 rates). Some progress has been made with reduction of stillbirths in late pregnancy (≥28 weeks' gestation). However, rates of early stillbirth (<28 weeks' gestation) remain intractable and new initiatives to reduce early stillbirth rates are needed to achieve this goal. Our previous study (MiNESS) informed about modifiable risk factors for stillbirth ≥28 weeks' gestation and were incorporated into national guidance to reduce stillbirth. However, there is an evidence gap related to modifiable risk factors for early stillbirth.
Aims and Objectives The overall aim of the study is to
- Identify modifiable risk factors for early stillbirth that are amenable to public health campaigns or adaptation of antenatal care. The study will specifically,
- Confirm or refute whether modifiable behavioural factors associated with late stillbirth are also independently associated with early stillbirth.
- Explore interactions between maternal characteristics (especially those relating to health inequalities including ethnicity and socioeconomic deprivation), fetal factors (including fetal growth restriction, reduced fetal movements) and early stillbirth risk.
- Determine differences in risk factor profiles by cause of death.
Methods This study uses a case-control design based upon that successfully used in the MiNESS study. The eligible population are women with a non-anomalous singleton pregnancy. "Cases" are women who have a stillbirth between 20+0 and 27+6 weeks' gestation and "Controls" are women who have an ongoing viable pregnancy at an equivalent gestational age. Controls will be randomly selected from participating maternity units' booking list at the appropriate week of pregnancy to match the unit's historic distribution of early stillbirths in a 1:2 (case:control) ratio. The study will recruit 316 cases and 632 controls; this gives 80% power to detect associations with an odds ratio ≥1.5. Participants will complete a researcher-administered questionnaire and relevant data will be extracted from medical records. Cases will be approached before hospital discharge, aiming to complete the research interview where possible within 3 weeks.
Unadjusted associations between early stillbirth and each exposure will be calculated. Logistic regression models, adjusted for confounding variables, will consider multiple exposures in relation to early stillbirth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: QuestionnaireRecently pregnant women/people who have experienced baby loss during pregnancy, labour or shortly after birth between 20-28 weeks of pregnancy |
| Controls | – | Other: QuestionnaireIndividuals still pregnant at same gestational age |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireInterviewer assisted completion of questionnaire. | Other | Cases, Controls |
Primary outcome
Maternal sleep position during pregnancy
Time frame: The night prior to questionnaire or the night prior to pregnancy loss
Self-reported sleep position
Duration of sleep during pregnancy
Time frame: The night prior to questionnaire or the night prior to pregnancy loss
Self-reported duration of sleep
Presence of snoring during pregnancy
Time frame: The night prior to questionnaire or the night prior to pregnancy loss
Self-reported presence of snoring during pregnancy
5 secondary outcomes
Maternal perception of fetal movement frequency
Time frame: Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
Maternal perception of fetal movement strength
Time frame: Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
Maternal caffeine exposure
Time frame: One month prior to questionnaire
Engagement with antenatal care
Time frame: Duration of Pregnancy (from booking to the time interview)
Exposure to Intimate Partner Violence
Time frame: Duration of Pregnancy (from booking to the time interview)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 38238057Heazell 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.
- Individual participant dataSharing planned: Undecided. Awaiting clearance from the Health Research Authority to share anonymised data for IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucy Higgins, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth and Fetal Death and Perinatal Death, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander E Heazell, PhD (+441612646484, alexander.heazell@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sleep position during pregnancy (time frame: The night prior to questionnaire or the night prior to pregnancy loss). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.