Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2018

Open Access 01-12-2018 | Research article

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

Authors: Jayne Budd, Tomasina Stacey, Bill Martin, Devender Roberts, Alexander E. P. Heazell

Published in: BMC Pregnancy and Childbirth | Issue 1/2018

Login to get access

Abstract

Background

The Midlands and North of England Stillbirth Study (MiNESS) was a case-control study of women who had a stillbirth or who had an ongoing pregnancy. During the set up phase questions were raised about whether interviewing women within six weeks of a stillbirth and recruiting women who were still pregnant into a “stillbirth” study was acceptable. This led to the research questions “whether it is appropriate to ask women who have recently experienced a stillbirth to participate in research?” and “whether it is appropriate to ask pregnant women to participate in a research project looking at factors associated with stillbirth.” This nested study aimed to describe the opinions of women approached to participate in MiNESS to explore their views and experiences of a research project focussed on stillbirth.

Methods

Semi- structured interviews were conducted at a single study site involved in MiNESS. Purposive sampling was used to obtain a sample of women who were approached following a stillbirth (case n = 6) and those who were approached during pregnancy who gave birth to a live born baby (control n = 6). These two groups of women were divided equally according to whether they participated in the main MiNESS questionnaire study and those who declined to do so (n = 3 in each group). Interview data were transcribed and analysed using thematic analysis to identify the most important factors in determining whether women participated in MiNESS.

Results

The following themes emerged from the analysis: participants’ understanding of research; approach by researcher; wanting to help; stillbirth taboo. These themes are explored individually in the manuscript. Participants reported positive views about research and previous participation in research studies. Respondents valued an initial approach from a member of staff already known to them. The taboo around stillbirth was a barrier to participation for some women with ongoing pregnancies.

Conclusions

Experiences and views regarding research differed between participants and non-participants in the MiNESS study. Participants reported a greater understanding of the importance and implications of clinical research. When designing future studies, the timing of approach, clarity of information and the person approaching potential participants should be considered to optimise recruitment.

Trial registration

NCT02025530 date registered: 01/01/2014.
Literature
1.
Manktelow BN, Smith LK, Prunet C, Smith PW, Boby T, Hyman-Taylor P, Kurinczuk JJ, Field DJ, Draper ES, on behalf of the MBRRACE-UK collaboration. MBRRACE-UK perinatal mortality surveillance report, UK perinatal deaths for births from January to December 2015. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester; 2017.
2.
Flenady V, Wojcieszek AM, Middleton P, Ellwood D, Erwich JJ, Coory M, et al. Stillbirths: recall to action in high-income countries. Lancet. 2016;387:691–702.CrossRefPubMed
3.
4.
Flenady V, Koopmans L, Middleton P, Frøen 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;377(9774):1331–40.CrossRefPubMed
5.
Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009;9(Suppl 1):S5.CrossRefPubMedPubMedCentral
6.
Heazell AE, Whitworth MK, Whitcombe J, Glover SW, Bevan C, Brewin J, Calderwood C, Canter A, Jessop F, Johnson G, Martin I, Metcalf L. Research priorities for stillbirth: process overview and results from UK stillbirth priority setting partnership. Ultrasound Obstet Gynecol. 2015;46(6):641–7.CrossRefPubMed
7.
Stacey T, Thompson JM, Mitchell EA, Ekeroma A, Zuccollo J. McCowan LM maternal perception of fetal activity and late stillbirth risk: findings from the Auckland stillbirth study. Birth. 2011;38(4):311–6.CrossRefPubMed
8.
Stacey T, Thompson JMD, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LME. The Auckland stillbirth study, a case–control study exploring modifiable risk factors for third trimester stillbirth: methods and rationale. Aust N Z J Obstet Gynaecol. 2011;51:3–8.CrossRefPubMed
9.
Breeze ACG, Statham H, Hackett GA, Jessop FA, Lees CC. Attitudes to perinatal postmortum: parental views about research participation. J Med Ethics. 2011;37(6):364–7.CrossRefPubMed
10.
Heazell A, Li M, Budd J, Thompson J, Stacey T, Cronin RS, Martin B, Roberts D, Mitchell EA, McCowan L. Association between maternal sleep practices and late stillbirth - findings from a stillbirth case-control study. BJOG. 2018;125(2):254–62.CrossRefPubMed
11.
Guest G, Bunce A, Johnson L. ‘How many interviews are enough? An Experiment with Data Saturation and Variability. Field Methods. 2006;18:59–82.CrossRef
12.
World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–4.CrossRef
13.
Braun V, Clarke V. Using thematic analysis in psychology. Quali Resin Psychology. 2006;3(2):77–101.CrossRef
14.
15.
Wendler R, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2006;3(2):e19.CrossRefPubMed
16.
Smyth RM, Duley L, Jacoby A, Elbourne D. Women’s experiences of participating in the Magpie trial: a postal survey in the United Kingdom. Birth. 2009;36(3):220–9.CrossRefPubMed
17.
Druegov K. Bereaved parents’ experience of research participation. Soc Sci Med. 2004;58(2):391–400.CrossRef
18.
Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction and late- pregnancy stillbirth: The Sydney stillbirth study. Obstet Gynecol. 2015;125(2):347–55.CrossRefPubMed
19.
Williams B, Irvine L, McGinnis AR, McMurdo ME, Crombie IK. When “no” might not quite mean “no”; the importance of informed and meaningful non-consent: results from a survey of individuals refusing participation in a health- related research project. BMC Health Serv Res. 2007;7:59.CrossRefPubMedPubMedCentral
20.
Heazell AE, Siassakos D, Blencowe H, Burden C, Bhutta ZA, Cacciatore J, Dang N, Das J, Flendy V, Gold KJ, Mensah OK, Millum J, Nuzum D, O’Donoghue K, Redshaw M, Rizvi A, Roberts T, Toyin Saraki HE, Storey C, Wojcieszek AM, Downe S. Stillbirths: economic and psychosocial consequences. Lancet. 2016;387(10018):604–16.CrossRefPubMed
Metadata
Title
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
Authors
Jayne Budd
Tomasina Stacey
Bill Martin
Devender Roberts
Alexander E. P. Heazell
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2018
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-018-1956-1

Other articles of this Issue 1/2018

BMC Pregnancy and Childbirth 1/2018 Go to the issue

Research article

Home deliveries in the capital: a qualitative exploration of barriers to institutional deliveries in peri-urban areas of Lusaka, Zambia

Research article

The relationship between maternal anxiety and cortisol during pregnancy and birth weight of chinese neonates

Research article

Mothers’ and fathers’ sense of security in the context of pregnancy, childbirth and the postnatal period: an integrative literature review

Research article

Midwives’ experience of their education, knowledge and practice around immersion in water for labour or birth

Research article

Influences on birth spacing intentions and desired interventions among women who have experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study

Research article

The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial