The Midlands and North of England Stillbirth Study
Condition: Stillbirth
MeSH terms: Stillbirth
Study type: Observational

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.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The sample will be recruited from maternity units in the Midlands and the North of England.
      
Biospecimen description: 
      Hair
    
Keywords: Stillbirth; Modifiable risk factors