Deciding to join a perinatal randomised controlled trial: Experiences and views of pregnant women enroled in the Magpie Trial

Midwifery

Volumn 28, Issue 4, 2012, Pages e538-e545

  Smyth, Rebecca M D ^a   Jacoby, Ann ^b   Elbourne, Diana ^c  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

^c LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

Interviews; Perinatal trials; Randomised controlled trials; Trial experience

Indexed keywords

EID: 84864136974     PISSN: 02666138     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.midw.2011.08.006     Document Type: Article

References (21)

1. Altman D., Carroli G., Duley L., et al. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet 2002, 359:1877-1890.
2. Baker L., Lavender T., Tincello D. Factors that influence women's decisions about whether to participate in research: an exploratory study. Birth 2005, 32:60-66.
3. Braunholtz D.A., Edwards S.J., Lilford R.J. Are randomized clinical trials good for us (in the short term)? Evidence for a 'trial effect'. Journal of Clinical Epidemiology 2001, 54:217-224.
4. Canvin K., Jacoby A. Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial. Trials 2006, 7:32.
5. Freedman B. Equipoise and the ethics of clinical research. New England Journal of Medicine 1987, 317:141-145.
6. Hofmeyr G.J., Neilson J.P., Alfirevic Z., Crowther C.A., Duley L., Gulmezoglu M., Gyte G.M.L., Hodnett E.D., et al. The Cochrane Pocketbook: Pregnancy and Childbirth 2008, John Wiley & Sons, Ltd.
7. Lupton M.G., Williams D.J. The ethics of research on pregnant women: is maternal consent sufficient?. British Journal of Obstetrics and Gynaecology 2004, 111:1307-1312.
8. Magpie C.G. The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia [ISRCTN86938761]. BMC Pregnancy Childbirth 2004, 4:5.
9. Magpie C.G. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for children at 18 months. British Journal of Obstetrics and Gynaecology 2007, 114:289-299.
10. Magpie C.G. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years. British Journal of Obstetrics and Gynaecology 2007, 114:300-309.
11. Mohanna K. Informed consent. Research in pregnancy brings special considerations. British Medical Journal 1997, 315:249-250.
12. Mohanna K., Tunna K. Withholding consent to participate in clinical trials: decisions of pregnant women. British Journal of Obstetrics and Gynaecology 1999, 106:892-897.
13. Morse J.M.F.P. Nursing Research: The Application of Qualitative Approaches 1996, Chapman & Hall, London.
14. Peppercorn J.M., Weeks J.C., Cook E.F., Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 2004, 363:263-270.
15. Polit D.F., Beck C.T. Essentials of Nursing Research: Methods, Appraisal and Utilisation 2006, Lippincott, Williams and Wilkins, Philadelphia.
16. Smyth R.M., Duley L., Jacoby A., Elbourne D. Women's experiences of participating in the Magpie Trial: a postal survey in the United Kingdom. Birth 2009, 36:220-229.
17. Smyth R.M., Spark P., Armstrong N., Duley L. Magpie Trial in the UK: methods and additional data for women and children at 2 years following pregnancy complicated by pre-eclampsia. BMC Pregnancy Childbirth 2009, 9:15.
18. Squires, J.P.L., Bricker, D., 1999. The ASQ User's Guide for the Ages and Stages Questionnaires: A Parent-Completed, Child Monitoring System. Baltimore, Paul Brookes Publishing Co.
19. Stiller C.A. Centralised treatment, entry to trials and survival. British Journal of Cancer 1994, 70:352-362.
20. Vernon G., Alfirevic Z., Weeks A. Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release Trial [ISRCTN13204258]. Trials 2006, 7:13.
21. Vist Gunn, E., Bryant, D., Somerville, L., Birminghem, T., Oxman Andrew, D., 2008. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database of Systematic Reviews. http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/MR000009/frame.html.