CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,030 enrolled
Drug / intervention
Questionnaireother
Likely dose
Not stated in record
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Search/NCT02025530
NCT02025530N/ACompleted

The Midlands and North of England Stillbirth Study - A Case-Control Study of Modifiable Factors in Late Stillbirth

University of Manchester·observational·Posted Jan 1, 2014·Updated Oct 11, 2019

In Brief

An observational study evaluating Questionnaire for Stillbirth. Completed, enrolled 1,030 participants across 4 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsStillbirth
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 1, 2014
Enrollment StartApr 1, 2014
Primary CompletionMar 31, 2016
Study CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.5 years ago

Interventions

Questionnaireother

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