Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.

BACKGROUND: Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. METHODS AND FINDINGS: We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women's decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women's willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention's risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women's participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people. CONCLUSIONS: This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.

The prevalence of and factors associated with prior induced abortion among women who gave birth in Victoria, 2010-2019.

OBJECTIVE: To assess the prevalence of a history of induced abortion among women who gave birth in Victoria during 2010-2019; to assess the association of socio-demographic factors with a history of induced abortion. STUDY DESIGN: Retrospective cohort study; analysis of cross-sectional perinatal data in the Victorian Perinatal Data Collection (VPDC). SETTING, PARTICIPANTS: All women who gave birth (live or stillborn) in Victoria, 1 January 2010 - 31 December 2019. MAIN OUTCOME MEASURES: Self-reported induced abortions prior to the index birth; outcome of the most recent pregnancy preceding the index pregnancy. RESULTS: Of the 766 488 women who gave birth during 2010-2019, 93 251 reported induced abortions (12.2%), including 36 938 of 338 547 nulliparous women (10.9%). Women living in inner regional (adjusted odds ratio [aOR], 0.94; 95% confidence interval [CI], 0.93-0.96) or outer regional/remote/very remote areas (aOR, 0.86; 95% CI, 0.83-0.89) were less likely than women in major cities to report induced abortions. The likelihood increased steadily with age at the index birth and with parity, and was also higher for women without partners at the index birth (aOR, 2.20; 95% CI, 2.16-2.25) and Aboriginal and Torres Strait Islander women (aOR, 1.32; 95% CI, 1.25-1.40). The likelihood was lower for women born in most areas outside Australia than for those born in Australia. The likelihood of a history of induced abortion declined across the study period overall (2019 v 2010: 0.93; 95% CI, 0.90-0.96) and for women in major cities (0.88; 95% CI, 0.84-0.91); rises in inner regional and outer regional/remote/very remote areas were not statistically significant. CONCLUSIONS: Access to abortion care in Victoria improved during 2010-2019, but the complex interplay between contraceptive use, unintended pregnancy, and induced abortion requires further exploration by remoteness of residence. Robust information about numbers of unintended pregnancies and access to reproductive health services are needed to guide national sexual and reproductive health policy and practice.