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/38238057/Actively Recruiting
Led by University of Manchester · Updated on 2026-02-27
948
Participants Needed
1
Research Sites
52 weeks
Total Duration
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 governments 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 200 and 276 weeks and women with ongoing pregnancies at matching gestational ages. Participants complete an interviewer-assisted questionnaire about their behaviors, diet, sleep, babys 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
Mothers Working to Prevent Early Stillbirth Study 20-28
A
Alexander E Heazell, PhD
L
Lucy Higgins, PhD
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University of Manchester
Lead Sponsor
University of Birmingham
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
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
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)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Alexander Edward Heazell, Jack Wilkinson, R Katie Morris...
https://pubmed.ncbi.nlm.nih.gov/38238057/University of Manchester
Lead Sponsor
University of Birmingham
Collaborating Sponsor