N/A
N=1,030
The Midlands and North of England Stillbirth Study
Stillbirth
Bottom Line
View on ClinicalTrials.gov: NCT02025530 ↗Enrolled (actual)
1,030
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Maternal Sleep Practices During Pregnancy — 140; 383; 73; 220 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Questionnaire (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Manchester
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Sleep Practices During Pregnancy |
140; 383; 73; 220; 19; 24 | — |
| SECONDARY Maternal Perception of Fetal Activity |
37; 254; 86; 63; 153; 397 | — |
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.
Eligibility Criteria
Inclusion Criteria: CASES
- Women who experience a stillbirth ≥28 weeks gestation in a participating unit.
Exclusion Criteria
- Fetal death prior to 28 weeks gestation.
- Women who's babies have a significant congenital abnormality.
- Women with multiple pregnancy.
- Maternal age below 16 years.
- Women unable to give informed consent.
Inclusion Criteria: CONTROLS
- Women with a normal pregnancy matched to gestation and unit of birth to the cases.
Exclusion Criteria
- Pregnancy under 28 weeks gestation.
- Women who's babies have a significant congenital abnormality.
- Women with multiple pregnancy.
- Maternal age below 16 years.
- Women unable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT02025530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.