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The Midlands and North of England Stillbirth Study

NCT02025530 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1030

Last updated 2019-10-11

Study results available
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Summary

The United Kingdom has one of the highest rates of stillbirth in Europe, with more than 4,000 stillbirths every year; which equates to more than 11 deaths every day. Furthermore, this rate has changed very little over the last 20 years. This loss of life and the adverse psychological consequences urgently needs addressing.

A recent New Zealand study investigating modifiable factors associated with stillbirth (the Auckland Stillbirth Study) found that mothers who did not go to sleep on their left side had a twofold risk of late stillbirth (≥28 weeks gestation) compared to mothers who did go to sleep on their left side. These novel findings need urgent confirmation.

This proposed study aims to confirm or refute these findings and to ascertain whether a preventative programme should be introduced. This proposed study aims to confirm or refute the findings of the Auckland Stillbirth Study.

Participants will be recruited from maternity units in the Midlands and North of England (led by centres in Liverpool, Manchester, West Yorkshire and Birmingham). 291 women with a singleton late stillbirth without congenital abnormality will be interviewed by research midwives shortly after the birth. A control group of 580 women with ongoing pregnancies will be interviewed at a gestation group matched to that at which stillbirths occurred. These data will determine whether an intervention study should be considered. If there is a causal relationship between maternal sleep position and late stillbirth we estimate that upto 37% of late stillbirths might be prevented.

Conditions

  • Stillbirth

Interventions

OTHER

Questionnaire

An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls

Sponsors & Collaborators

  • University of Manchester

    lead OTHER

Principal Investigators

  • Tomasina Stacey · Mid Yorkshire NHS Trust

  • Edwin Mitchell · University of Auckland, New Zealand

  • Lesley McCowan · University of Auckland, New Zealand

  • Bill Martin · Birmingham Women's Hospital NHS Foundation Trust

  • Devender Roberts · Liverpool Women's NHS Foundation Trust

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2016-03-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025530 on ClinicalTrials.gov