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The Midlands and North of England Stillbirth Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02025530
Acronym
MiNESS
Enrollment
1030
Registered
2014-01-01
Start date
2014-04-01
Completion date
2017-12-31
Last updated
2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stillbirth

Keywords

Stillbirth, Modifiable risk factors

Brief 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.

Detailed description

The death of an unborn child is a prevalent and tragic public health problem which currently affects millions of families worldwide. Late stillbirth (at or beyond 28 weeks of gestation) is one of the few potentially avoidable maternal and child health problems where the rate of decline in high income countries has slowed in recent decades \[1\]. The United Kingdom currently has one of the highest rates of stillbirth in Europe, ranking 33rd out of 35 high income countries. The variations in stillbirth rates between high income countries suggest that it should be possible to make further reductions in late stillbirths. The estimated annual reduction in rates of late stillbirth over recent decades is about 1.1% \[1\], compared to 2.1% for neonatal death rates, with a resultant increase in the proportion of perinatal deaths (stillbirths plus neonatal deaths) attributable to stillbirth \[2\]. The Lancet Stillbirth Series \[1, 3, 4\] has highlighted the silent but prevalent public health problem of stillbirth and together with Sands and the Royal College Of Obstetricians and Gynaecologists has called for research to address these unacceptably high rates. Current established risk factors for late stillbirth in high income countries include: advanced maternal age (\>35 years) \[5\], high pre-pregnancy body mass index (BMI) \[6\], smoking \[7\], reduced antenatal care attendance \[8\], low socioeconomic status \[8\] and small for gestational age (SGA) infants \[9\]. A meta-analysis of population based studies addressing risk factors for stillbirth found that the three most important modifiable risk factors were overweight and obesity (population attributable risk 818%) advanced maternal age (population attributable risk 68%), and smoking (population attributable risk 47%) \[3\]. Of these only, cigarette smoking may be realistically addressed after pregnancy has started. There has been limited research investigating the role of novel, modifiable factors which have the potential to advance knowledge and address the important gaps in the field of stillbirth research. This study aims to explore modifiable risk factors for late stillbirth in the UK and to substantiate the recent identification of a new modifiable risk factor for unexpected late pregnancy stillbirths. In the Auckland Stillbirth Study \[10\] our New Zealand collaborators discovered an approximately two-fold increase in late stillbirth with non-left sided maternal sleep position on the night before the baby died. In addition, women who did not get up at night and those who slept during the day were also at increased risk of stillbirth. The strength of this primary finding was unanticipated and now maternal sleep position requires urgent, rigorous evaluation in another population. MiNESS aims to address these factors. This multi-centered case control study will recruit 291 women who have experienced a late (≥28 weeks gestation) matched with 580 women who have a continuing pregnancy at the same gestation (controls). The women will be interviewed by an experienced research midwife and an in depth questionnaire will be completed. Analysis will be carried out using the standard Mantel-Haenszel odds ratio analysis used in case-control studies. Unconditional logistic regression will be used to adjust for potential confounders and to determine the presence of interactions.

Interventions

OTHERQuestionnaire

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

Sponsors

University of Manchester
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maternal Sleep Practices During PregnancyOne night prior to questionnaireSelf-reported going to sleep position in late pregnancy

Secondary

MeasureTime frameDescription
Maternal Perception of Fetal ActivityTwo weeks prior to stillbirth / interviewMaternal Perception of Fetal Activity reported via the researcher-administered questionnaire.

Countries

United Kingdom

Participant flow

Recruitment details

Participants were recruited between April 2014 and March 2016 from 41 maternity units around the United Kingdom.

Pre-assignment details

This was a case-control study, so participants were not assigned to a specific arm/group. 5 cases (women who had a stillbirth) were excluded prior to analysis because the baby was found to have a congenital anomaly at post-mortem examination. One control (women with a live baby at interview) was excluded because she had a stillborn baby.

Participants by arm

ArmCount
Cases (Stillbirth)
A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
291
Controls (Live Pregnancy)
A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
733
Total1,024

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNo longer met elligibility criteria51

Baseline characteristics

CharacteristicCases (Stillbirth)Controls (Live Pregnancy)Total
Age, Continuous30.0 years
STANDARD_DEVIATION 5.9
30.4 years
STANDARD_DEVIATION 5.1
30.3 years
STANDARD_DEVIATION 5.3
Sex: Female, Male
Female
291 Participants733 Participants1024 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2960 / 734
other
Total, other adverse events
0 / 2960 / 734
serious
Total, serious adverse events
0 / 2960 / 734

Outcome results

Primary

Maternal Sleep Practices During Pregnancy

Self-reported going to sleep position in late pregnancy

Time frame: One night prior to questionnaire

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cases (Stillbirth)Maternal Sleep Practices During PregnancyUnknown15 Participants
Cases (Stillbirth)Maternal Sleep Practices During PregnancyLeft140 Participants
Cases (Stillbirth)Maternal Sleep Practices During PregnancyRight73 Participants
Cases (Stillbirth)Maternal Sleep Practices During PregnancyBack19 Participants
Cases (Stillbirth)Maternal Sleep Practices During PregnancyTummy3 Participants
Cases (Stillbirth)Maternal Sleep Practices During PregnancyPropped9 Participants
Cases (Stillbirth)Maternal Sleep Practices During PregnancyVariable32 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyUnknown11 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyTummy4 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyLeft383 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyVariable76 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyRight220 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyPropped15 Participants
Controls (Live Pregnancy)Maternal Sleep Practices During PregnancyBack24 Participants
Secondary

Maternal Perception of Fetal Activity

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

Time frame: Two weeks prior to stillbirth / interview

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cases (Stillbirth)Maternal Perception of Fetal ActivityIn last 2 weeks did movements increase?37 Participants
Cases (Stillbirth)Maternal Perception of Fetal ActivityIn last 2 weeks did movements decrease?86 Participants
Cases (Stillbirth)Maternal Perception of Fetal ActivityMovements stayed the same153 Participants
Cases (Stillbirth)Maternal Perception of Fetal ActivityUnsure15 Participants
Controls (Live Pregnancy)Maternal Perception of Fetal ActivityUnsure19 Participants
Controls (Live Pregnancy)Maternal Perception of Fetal ActivityIn last 2 weeks did movements increase?254 Participants
Controls (Live Pregnancy)Maternal Perception of Fetal ActivityMovements stayed the same397 Participants
Controls (Live Pregnancy)Maternal Perception of Fetal ActivityIn last 2 weeks did movements decrease?63 Participants
Post Hoc

Screening for Gestational Diabetes and Fasting Plasma Glucose

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

Time frame: During index pregnancy

Population: Women were excluded from this analysis if they had pre-existing diabetes. Women should have been screened using oral glucose tolerance test if they had a positive family history, were of South Asian or Black Caribbean ethnicity, had a body mass index ≥ 30 kg/m2, or previous pregnancy effected by GDM or macrosomic (birthweight ≥4.5 kg) birth.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Cases (Stillbirth)Screening for Gestational Diabetes and Fasting Plasma GlucoseWomen screened by Oral Glucose Tolerance Test94 Participants
Cases (Stillbirth)Screening for Gestational Diabetes and Fasting Plasma GlucoseProportion Diagnosed with GDM6 Participants
Controls (Live Pregnancy)Screening for Gestational Diabetes and Fasting Plasma GlucoseWomen screened by Oral Glucose Tolerance Test277 Participants
Controls (Live Pregnancy)Screening for Gestational Diabetes and Fasting Plasma GlucoseProportion Diagnosed with GDM30 Participants

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026