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. 2025 Jun 4;25(1):651.
doi: 10.1186/s12884-025-07759-x.

What influences women's decisions to participate in trials for prevention of venous thromboembolism during pregnancy and the puerperium: a qualitative study

Fiona C Sampson  1 , Sarah Davis  2 , Maxine Kuczawski  2 , Rosemary Carser  3 , Beverley J Hunt  4 , Steve Goodacre  2 , Abdullah Pandor  2 , Catherine Nelson-Piercy  5 , Jahnavi Daru  6
Affiliations

What influences women's decisions to participate in trials for prevention of venous thromboembolism during pregnancy and the puerperium: a qualitative study

Fiona C Sampson et al. BMC Pregnancy Childbirth. .

Abstract

Background: Thromboprophlyaxis for the prevention of venous thromboembolism during pregnancy and the puerperium is widespread, but there is a lack of evidence on the risks and benefits of thromboprophylaxis within this population. Trials involving pregnant women often struggle to recruit and retain participants which makes It difficult to improve the evidence base. We undertook qualitative evaluation of patient perspectives of pregnancy/postpartum thromboprophylaxis to understand willingness to participate in future trials.

Methods: We undertook four focus groups of women who had thromboprophylaxis due to prior VTE (n = 10) or been offered thromboprophylaxis due to other risk factors (n = 12) during pregnancy and the puerperium. Focus groups were held online between November 2021 and January 2022. We recruited via social media and national special interest groups representing diverse cultural and socio-economic backgrounds, sampling purposively for condition, age, ethnicity, and socio-economic status. Participants received a £50 voucher. We transcribed focus groups and analysed data using thematic analysis.

Results: A lack of knowledge around the risks and benefits of thromboprophylaxis influenced how women perceived future trial participation. Limited understanding of thromboprophylaxis risks led to a lack of equipoise among participants who only identified benefits from treatment. Some women were unaware of why they had been given thromboprophylaxis but still perceived placebo as an inferior option. Concerns around injecting thromboprophylaxis were often minimised and ignored by healthcare professionals yet influenced treatment adherence. However, these negative experiences also motivated women to participate in future trials to receive a higher standard of care, as well as improving future care for others.

Conclusions: Trial treatment adherence may be affected by negative experiences of injecting and limited understanding of why they had been offered thromboprophylaxis. To improve recruitment and retention in pregnancy and puerperium clinical trials, women need to be given clear explanations of the risks and benefits of treatment and understand where there is genuine clinical equipoise. Improved communication may also improve the experience and treatment adherence for women currently being offered thromboprophylaxis.

Keywords: Communication; Pregnancy; Qualitative research; Thromboprophylaxis; Trial participation; Women’s health.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study adhered to the Declaration of Helsinki and was approved by the University of Sheffield Research Ethics Committee (University of Sheffield 038511) in March 2021. All participants gave written informed consent and provided consent for the publication of anonymised quotations. Consent for publication: All participants signed a consent form giving permission for anonymised quotations to be used in publications and research outputs. Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare: the research described was conducted as part of a wider project funded by theNational Institute for Health Research Health Technology Assessment (NIHR HTA) programme(project number NIHR131021); S Goodacre is chair of the NIHR HTA Clinical Trials Unit StandingAdvisory Committee, is a member of the NIHR HTA Programme Oversight Committee 2009 - 2023and has been a member of a number of NIHR Committees from 2009 to 2022; BJ Hunt, waspreviously involved in developing relevant National Institute for Health and Care Excellence (NICE)guidance on prevention and management of venous thromboembolic disease, and founder and atrustee of Thrombosis UK and previous Chair of the Steering Group of World Thrombosis Day; CNelson-Piercy reports personal fees from Sanofi and UCB, and was the lead developer of the RoyalCollege of Obstetricians and Gynaecologists (RCOG) Green Top Guideline on thromboprophylaxis inpregnancy (37a); J Daru was an author on RCOG’s Covid-19 guidance; no other relationships oractivities that could appear to have influenced the submitted work. Copyright/license for publication: All work funded by the NIHR is subject to Crown Copyright. We are therefore unable to assign copyright to the journal but will grant a non-exclusive licence (CC-BY) on a worldwide basis to permit this article (if accepted) to be published in BMC Pregnancy and Childcare.

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