An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study

Deirdre Hayes-Ryan, Sarah Meaney, Caroline Nolan, Keelin O'Donoghue, Deirdre Hayes-Ryan, Sarah Meaney, Caroline Nolan, Keelin O'Donoghue

Abstract

Objective: To explore pregnant women's views of participation in a clinical research trial while pregnant.

Design: Prospective nested qualitative cohort study embedded within a national, multi-site randomized controlled trial of a diagnostic test for preeclampsia: Placental Growth Factor. One-to-one in-depth semi-structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site. The interviews were conducted in private, recorded digitally and transcribed verbatim.

Setting: Single tertiary maternity hospital currently recruiting eligible women onto an on-going randomized controlled trial (NCT02881073).

Participants: Women who had participated in the PARROT Ireland randomized controlled trial during their recent pregnancy.

Methods: Thematic analysis was utilized. Each line of the transcribed interviews was coded into a category by two researchers. The resultant categories were reviewed, and those with similarities were pooled allowing the development of themes.

Main outcome measures: Women's opinions and experience of participation in a randomized controlled trial of an interventional diagnostic test during their pregnancy.

Results: Four major themes were identified as follows: (a) Understanding of preeclampsia, (b) Motivators for clinical trial participation, (c) Barriers to decision making and (d) Influence of PARROT Ireland on pregnancy experience.

Conclusions: Women are generally interested and positively inclined to participate in research during pregnancy. The potential of risk is an important consideration for eligible pregnant woman. Information and support by both researchers and clinicians are paramount in aiding women's understanding of a research trial.

Keywords: diagnostic test; preeclampsia; pregnancy; qualitative; randomized controlled trial; research.

Conflict of interest statement

The authors report no conflicts of interest.

© 2019 The Authors. Health Expectations published by John Wiley & Sons Ltd.

References

    1. Akobeng AK. Understanding randomised controlled trials. Arch Dis Child. 2005;90(8):840‐844.
    1. Feinleib M. A Dictionary of Epidemiology, Fourth Edition. Edited by John M. Last, Robert A. Spasoff, and Susan S. Harris. American journal of epidemiology. 2001;154(1):93‐94. 10.1093/aje/154.1.93-a.
    1. Allesee L, Gallagher CM. Pregnancy and protection: the ethics of limiting a pregnant woman's participation in clinical trials. J Clin Res Bioeth. 2011;2(108):1000108.
    1. Charco RA. Protecting us to death: women, pregnancy and clinical research trials. St Louis Univ Law J. 1993;38:135‐187.
    1. Chambers CD, Polifka JE, Friedman JM. Drug safety in pregnant women and their babies: ignorance not bliss. Clin Pharmacol Ther. 2008;83(1):181‐183.
    1. Barthow C, Wickens K, Stanley T, et al. The probiotics in pregnancy study (PiP Study): rationale and design of a double‐blind randomised controlled trial to improve maternal health during pregnancy and prevent infant eczema and allergy. BMC Pregnancy Childbirth. 2016;16(1):133.
    1. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004;191(2):398‐407.
    1. Rubin R. Addressing barriers to inclusion of pregnant women in clinical trials. JAMA. 2018;320(8):742‐744.
    1. Grivell RM, Alfirevic Z, Gyte GM, Devane D. Antenatal cardiotocography for fetal assessment. Cochrane Database Syst Rev. 2015;9:Cd007863.
    1. Berghella V, Saccone G. Fetal fibronectin testing for prevention of preterm birth in singleton pregnancies with threatened preterm labor: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2016;215(4):431‐438.
    1. Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1(2):5‐22.
    1. Baylis F. Pregnant women deserve better. Nature. 2010;465:689.
    1. Macklin R. Enrolling pregnant women in biomedical research. Lancet. 2010;375(9715):632‐633.
    1. Noah BA.The Inclusion of Pregnant Women in Clinical Research St Louis University Journal of Health Law and Policy. Western New England University School of Law Legal Studies Research Paper No 14–9 2014;Vol. 7:353, 2014.
    1. Institute of Medicine Committee on E , Legal Issues Relating to the Inclusion of Women in Clinical S In Mastroianni AC, Faden R, Federman D, eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Vol I Washington (DC): National Academies Press (US) Copyright 1994 by the National Academy of Sciences. All rights reserved; 1994.
    1. Pj H. F. D. A. Ends Ban on Women in Drug Testing. New York Times.1993.
    1. Health NIo . NIH Policy and guidelines on the inclusion of women and minorities as subjects in clinical research 2001. Accessed June 2019. Available from
    1. Health NIo . NIH policy and guidelines on the inclusion of children as participants in research involving human subjects 1998. Accessed June 2019. Available from
    1. Institute of Medicine Committee on Ethical Considerations for Revisions to DRfPoPIiR . The National Academies Collection: Reports funded by National Institutes of Health In Gostin LO, Vanchieri C, Pope A, eds. Ethical Considerations for Research Involving Prisoners. Washington (DC): National Academies Press (US) National Academy of Sciences; 2007.
    1. van der Graaf R, van der Zande I, den Ruijter HM, et al. Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach. Trials. 2018;19(1):78.
    1. van der Zande I, van der Graaf R, Oudijk MA. van Delden JJM. A qualitative study on acceptable levels of risk for pregnant women in clinical research. BMC medical ethics. 2017;18(1):35.
    1. Meshaka R, Jeffares S, Sadrudin F, Huisman N, Saravanan P. Why do pregnant women participate in research? a patient participation investigation using Q‐Methodology. Health Expect. 2017;20(2):188‐197.
    1. Rodger MA, Makropoulos D, Walker M, Keely E, Karovitch A, Wells PS. Participation of pregnant women in clinical trials: will they participate and why? Am J Perinatol. 2003;20(2):69‐76.
    1. Baker L, Lavender T, Tincello D. Factors that influence women's decisions about whether to participate in research: an exploratory study. Birth. 2005;32(1):60‐66.
    1. Matsui D. Adherence with drug therapy in pregnancy. Obstet Gynecol Int. 2012;2012:796590.
    1. Mohanna K, Tunna K. Withholding consent to participate in clinical trials: decisions of pregnant women. Br J Obstet Gynaecol. 1999;106(9):892‐897.
    1. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Women's Health Issues. 2013;23(1):e39‐e45.
    1. McDonald AM, Knight RC, Campbell MK, et al. What influences recruitment to randomised controlled trials? a review of trials funded by two UK funding agencies. Trials. 2006;7:9.
    1. Hayes‐Ryan D, Hemming K, Breathnach F, et al. PARROT Ireland: placental growth factor in Assessment of women with suspected pre‐eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial research study protocol. BMJ Open. 2019;9(2):e023562.
    1. Kenyon S, Dixon‐Woods M, Jackson CJ, Windridge K, Pitchforth E. Participating in a trial in a critical situation: a qualitative study in pregnancy. Qual saf Health care. 2006;15(2):98‐101.
    1. Monteiro TM, Katz L, Bento SF, Amorim MM, Moriel PC, Pacagnella RC. Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis. BMC pregnancy childbirth. 2019;19(1):97.
    1. Ballantyne A, Pullon S, Macdonald L, Barthow C, Wickens K, Crane J. The experiences of pregnant women in an interventional clinical trial: research in pregnancy ethics (RIPE) study. Bioethics. 2017;31(6):476‐483.
    1. Smyth RM, Jacoby A, Elbourne D. Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the Magpie Trial. Midwifery. 2012;28(4):E478‐E485.
    1. McLeod SA. Qualitative vs. quantitative research. Simply Psychology. 2017.
    1. Berg B. An Introduction to Content Analysis. Qualitative Research Methods for the Social Sciences: Allyn and Bacon; 2007.
    1. Rosenthal M. Qualitative research methods: Why, when, and how to conduct interviews and focus groups in pharmacy research. Currents in Pharmacy Teaching and Learning. 2016;8(4):509‐516.
    1. Clarke V, Braun V. Successful qualitative research: a practical guide for beginners 2013.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77‐101.
    1. van der Zande I, van der Graaf R, Hooft L, van Delden J. Facilitators and barriers to pregnant women’s participation in research: a systematic review. Women and Birth. 2018;31(5):350‐361.
    1. Hawkes N. Trial of viagra for fetal growth restriction is halted after baby deaths. BMJ. 2018;362:k3247.
    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(9321):1877‐1890.
    1. Kenyon SL, Taylor DJ, Tarnow‐Mordi W. Broad‐spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. Lancet. 2001;357(9261):979‐988.
    1. Grady C, Cummings SR, Rowbotham MC, McConnell MV, Ashley EA, Kang G. Informed Consent. N Engl J Med. 2017;376(9):856‐867.
    1. Potter JE, McKinley S, Delaney A. Research participants’ opinions of delayed consent for a randomised controlled trial of glucose control in intensive care. Intensive Care Med. 2013;39(3):472‐480.
    1. The European Union J , The USA, Health Canada and Switzerland. ICH HARMONISED GUIDELINE. 11 June 2015.
    1. Commission E . 2018 reform of EU data protection rules. European Commission; 2018.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere