The Midlands and North of England Stillbirth Study

NCT02025530 | Completed Results

• 1 other identifier: GN2156
• Study Type: observational
• Target: 1,030
• Locations: 1 country
• Sites: 4

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.

Conditions

Stillbirth

Keywords

Stillbirth; Modifiable risk factors

Outcome Measures

Primary Outcomes (1)

• Maternal Sleep Practices During Pregnancy

  Self-reported going to sleep position in late pregnancy

  One night prior to questionnaire

Secondary Outcomes (1)

• Maternal Perception of Fetal Activity

  Two weeks prior to stillbirth / interview

Study Arms (2)

Cases

A structured questionnaire will be administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality.

Other: Questionnaire

Controls

A structured questionnaire will be 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.

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Cases; Controls

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample will be recruited from maternity units in the Midlands and the North of England.

You may qualify if:

• Women who experience a stillbirth ≥28 weeks gestation in a participating unit.

You may not qualify if:

• 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.
• Women with a normal pregnancy matched to gestation and unit of birth to the cases.
• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (4)

Liverpool Women's NHS Foundation Trust

Liverpool, Merseyside, L8 7SS, United Kingdom

Location

Birmingham Women's Hospital NHS Foundation Trust

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Mid Yorkshire NHS Trust

Dewsbury, Yorkshire, WF13 4HS, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (13)

• Cousens S, Blencowe H, Stanton C, Chou D, Ahmed S, Steinhardt L, Creanga AA, Tuncalp O, Balsara ZP, Gupta S, Say L, Lawn JE. National, regional, and worldwide estimates of stillbirth rates in 2009 with trends since 1995: a systematic analysis. Lancet. 2011 Apr 16;377(9774):1319-30. doi: 10.1016/S0140-6736(10)62310-0.

  PMID: 21496917 BACKGROUND

• Rajaratnam JK, Marcus JR, Flaxman AD, Wang H, Levin-Rector A, Dwyer L, Costa M, Lopez AD, Murray CJ. Neonatal, postneonatal, childhood, and under-5 mortality for 187 countries, 1970-2010: a systematic analysis of progress towards Millennium Development Goal 4. Lancet. 2010 Jun 5;375(9730):1988-2008. doi: 10.1016/S0140-6736(10)60703-9. Epub 2010 May 27.

  PMID: 20546887 BACKGROUND

• Flenady V, Koopmans L, Middleton P, Froen JF, Smith GC, Gibbons K, Coory M, Gordon A, Ellwood D, McIntyre HD, Fretts R, Ezzati M. Major risk factors for stillbirth in high-income countries: a systematic review and meta-analysis. Lancet. 2011 Apr 16;377(9774):1331-40. doi: 10.1016/S0140-6736(10)62233-7.

  PMID: 21496916 BACKGROUND

• Froen JF, Cacciatore J, McClure EM, Kuti O, Jokhio AH, Islam M, Shiffman J; Lancet's Stillbirths Series steering committee. Stillbirths: why they matter. Lancet. 2011 Apr 16;377(9774):1353-66. doi: 10.1016/S0140-6736(10)62232-5.

  PMID: 21496915 BACKGROUND

• Rasmussen S, Albrechtsen S, Irgens LM, Dalaker K, Maartmann-Moe H, Vlatkovic L, Markestad T. Risk factors for unexplained antepartum fetal death in Norway 1967-1998. Early Hum Dev. 2003 Feb;71(1):39-52. doi: 10.1016/s0378-3782(02)00111-1.

  PMID: 12614949 BACKGROUND

• Stephansson O, Dickman PW, Johansson A, Cnattingius S. Maternal weight, pregnancy weight gain, and the risk of antepartum stillbirth. Am J Obstet Gynecol. 2001 Feb;184(3):463-9. doi: 10.1067/mob.2001.109591.

  PMID: 11228504 BACKGROUND

• Wisborg K, Kesmodel U, Henriksen TB, Olsen SF, Secher NJ. Exposure to tobacco smoke in utero and the risk of stillbirth and death in the first year of life. Am J Epidemiol. 2001 Aug 15;154(4):322-7. doi: 10.1093/aje/154.4.322.

  PMID: 11495855 BACKGROUND

• Huang DY, Usher RH, Kramer MS, Yang H, Morin L, Fretts RC. Determinants of unexplained antepartum fetal deaths. Obstet Gynecol. 2000 Feb;95(2):215-21. doi: 10.1016/s0029-7844(99)00536-0.

  PMID: 10674582 BACKGROUND

• Cnattingius S, Haglund B, Kramer MS. Differences in late fetal death rates in association with determinants of small for gestational age fetuses: population based cohort study. BMJ. 1998 May 16;316(7143):1483-7. doi: 10.1136/bmj.316.7143.1483.

  PMID: 9582131 BACKGROUND

• Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.

  PMID: 21673002 BACKGROUND

• Budd J, Stacey T, Martin B, Roberts D, Heazell AEP. 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. BMC Pregnancy Childbirth. 2018 Aug 6;18(1):317. doi: 10.1186/s12884-018-1956-1.

  PMID: 30081858 DERIVED

• Heazell AEP, Budd J, Li M, Cronin R, Bradford B, McCowan LME, Mitchell EA, Stacey T, Martin B, Roberts D, Thompson JMD. Alterations in maternally perceived fetal movement and their association with late stillbirth: findings from the Midland and North of England stillbirth case-control study. BMJ Open. 2018 Jul 6;8(7):e020031. doi: 10.1136/bmjopen-2017-020031.

  PMID: 29982198 DERIVED

• Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171.

  PMID: 24885461 DERIVED

Biospecimen

Retention: NONE RETAINED

Hair

MeSH Terms

Conditions

Stillbirth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Professor Alexander Heazell
• Organization: University of Manchester

alexander.heazell@manchester.ac.uk

+441612766484

Study Officials

• Tomasina Stacey

  Mid Yorkshire NHS Trust

  PRINCIPAL INVESTIGATOR

• Edwin Mitchell

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

• Lesley McCowan

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

• Bill Martin

  Birmingham Women's Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Devender Roberts

  Liverpool Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer in Obstetrics

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 1, 2014
• Study Start: April 1, 2014
• Primary Completion: March 31, 2016
• Study Completion: December 31, 2017
• Last Updated: October 11, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-10

Locations

GB (4)