Last reviewed · How we verify

NCT02025530: MiNESS

The Midlands and North of England Stillbirth Study

Completed Results posted Last updated 11 October 2019
What this trial tests

trial testing Questionnaire in Stillbirth in 1,030 participants. Completed in 31 December 2017.

Timeline
1 April 2014
Primary endpoint
31 March 2016
31 December 2017

Quick facts

Lead sponsorUniversity of Manchester
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,030
Start date1 April 2014
Primary completion31 March 2016
Estimated completion31 December 2017
Sites4 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Manchester

Who can join

Adults 16 to 50, female only, with Stillbirth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maternal Sleep Practices During Pregnancy Primary · One night prior to questionnaire

Self-reported going to sleep position in late pregnancy

GroupValue95% CI
Cases (Stillbirth)140
Controls (Live Pregnancy)383
Cases (Stillbirth)73
Controls (Live Pregnancy)220
Cases (Stillbirth)19
Controls (Live Pregnancy)24
Cases (Stillbirth)3
Controls (Live Pregnancy)4
Maternal Perception of Fetal Activity Secondary · Two weeks prior to stillbirth / interview

Maternal Perception of Fetal Activity reported via the researcher-administered questionnaire.

GroupValue95% CI
Cases (Stillbirth)37
Controls (Live Pregnancy)254
Cases (Stillbirth)86
Controls (Live Pregnancy)63
Cases (Stillbirth)153
Controls (Live Pregnancy)397
Cases (Stillbirth)15
Controls (Live Pregnancy)19
Screening for Gestational Diabetes and Fasting Plasma Glucose Secondary · During index pregnancy

Performance of 75g oral glucose tolerance test and the results of glucose tolerance test in cases and controls

Women screened by Oral Glucose Tolerance Test
GroupValue95% CI
Cases (Stillbirth)94
Controls (Live Pregnancy)277
Proportion Diagnosed with GDM
GroupValue95% CI
Cases (Stillbirth)6
Controls (Live Pregnancy)30

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Association between maternal sleep practices and late stillbirth - findings from a stillbirth case-control study.
    Heazell A, Li M, Budd J, Thompson J, et al · · 2018 · cited 62× · PMID 29152887 · DOI 10.1111/1471-0528.14967
  2. Alterations in maternally perceived fetal movement and their association with late stillbirth: findings from the Midland and North of England stillbirth case-control study.
    Heazell AEP, Budd J, Li M, Cronin R, et al · · 2018 · cited 43× · PMID 29982198 · DOI 10.1136/bmjopen-2017-020031
  3. The Midland and North of England Stillbirth Study (MiNESS).
    Platts J, Mitchell EA, Stacey T, Martin BL, et al · · 2014 · cited 21× · PMID 24885461 · DOI 10.1186/1471-2393-14-171
  4. Women's experiences of being invited to participate in a case-control study of stillbirth - findings from the Midlands and North of England Stillbirth Study.
    Budd J, Stacey T, Martin B, Roberts D, et al · · 2018 · cited 3× · PMID 30081858 · DOI 10.1186/s12884-018-1956-1

Verify or expand the search:

Other trials of Questionnaire

Trials testing the same drug.

Other recruiting trials for Stillbirth

Currently open trials in the same condition.

Other University of Manchester trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02025530.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing