Mothers working to prevent early stillbirth study (MiNESS 20-28): a case-control study protocol.
Alexander Edward Heazell, Jack Wilkinson, R Katie Morris...
https://pubmed.ncbi.nlm.nih.gov/38238057Actively Recruiting
Age: 16Years - 50Years
FEMALE
Healthy Volunteers
ID06005272
Mothers Working to Prevent Early Stillbirth Study 20-28
Led by University of Manchester · Updated on 2026-02-27
948
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Manchester
Lead Sponsor
U
University of Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating factors linked to pregnancy losses between 20 and 28 weeks of pregnancy, focusing on early stillbirths. The study aims to find modifiable causes of these losses that could be influenced by changes in maternal behavior or healthcare. This effort supports the UK government's goal to reduce stillbirths by 50% by 2025, addressing a stage of pregnancy where stillbirth rates have not declined. The study uses a case-control design involving women who experienced stillbirths between 20+0 and 27+6 weeks and women with ongoing pregnancies at matching gestational ages. Participants complete an interviewer-assisted questionnaire about their behaviors, diet, sleep, baby's movements, and pregnancy care. Data from medical records will also be used. Cases are approached within about three weeks of hospital discharge. Participants will provide information through questionnaires and medical record reviews. Researchers will measure factors like maternal sleep position, sleep duration, snoring, perception of fetal movements, caffeine intake, antenatal care engagement, and exposure to intimate partner violence. The study will compare these factors between women who had early stillbirths and those with live ongoing pregnancies. Findings aim to inform clinical guidelines and public health campaigns to reduce early stillbirths.
CONDITIONS
Brief Title
Mothers Working to Prevent Early Stillbirth Study 20-28
Who Can Participate
Age: 16Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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
- Baby has no evidence of congenital anomaly
- Able to give written informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility and consent
Diagnostic Evaluation
Duration - Up to 3 weeks following delivery or during ongoing pregnancy at target gestation
Participants complete a researcher-administered questionnaire and relevant data are extracted from medical records to assess modifiable risk factors for early stillbirth.
1 to 2 visits depending on participant status (case or control)
Long-term Monitoring
Duration - Up to study completion in 2027
Participants' data are analyzed to explore risk factors and outcomes related to early stillbirth between 20 and 28 weeks' gestation.
No additional participant visits; follow-up is via data analysis
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
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Research Team
A
Alexander E Heazell, PhD
L
Lucy Higgins, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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