Advancing research in pregnancy during COVID-19: Missed opportunities and momentum in the US

Jaffe, Elana; Lyerly, Anne Drapkin; Goldfarb, Ilona T.

doi:10.1016/j.medj.2021.04.019

Cited by 4 publications

(5 citation statements)

References 14 publications

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“…Although evidence confirming elevated risk from COVID-19 infection in pregnancy was reported, pregnant women have been excluded from most studies of COVID-19 treatments as well as from COVID-19 vaccine trials [ 21 ]. This exclusion could be the encouragement needed for pregnant/lactating women with a health-related profession to accept COVID-19 vaccines.…”

Section: Discussionmentioning

confidence: 99%

Mothers’ Impressions and Beliefs About Taking a Booster Dose for COVID-19 Vaccine During Pregnancy and Lactation

Taybeh¹,

Alsharedeh²,

Hamadneh³

2022

Cureus

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Objectives: This study aimed to explore perceptions and willingness to get coronavirus disease 2019 (COVID-19) booster vaccination among pregnant and lactating women in Jordan.Methods: A cross-sectional study using a 29-item web-based questionnaire was conducted. Sociodemographic characteristics, vaccine acceptance, confidence in the booster dose of COVID-19 vaccine, perception of risk for COVID-19, and acceptance to participate in COVID-19 booster vaccine clinical trials were prospectively evaluated. Logistic regression was used to identify factors that might affect the participants' acceptance of a COVID-19 vaccine and their willingness to enroll in clinical trials of a booster dose of COVID-19 vaccine.Results: Among all participants (pregnant and lactating women, n = 584), 328 (56.2%) intended to receive the booster dose of the COVID-19 vaccine. Predictors of booster dose acceptance were a medical-related degree (OR 1.62, CI 1.06-2.5, p = 0.028), income (OR 0.677, CI 0.52-0.88, p = 0.004), living residency (OR 0.44, CI 0.32-0.60, p < 0.001), knowing pregnant/lactating women previously infected with infectious microbe (OR 1.539, CI 1.07-2.23, p = 0.022), commitment to immunization for children (OR 3.01, CI 1.03-8.82, p = 0.044), receiving an influenza vaccine (OR 1.46, CI 1.04-2.05, p = 0.031), and worried about infectious microbes (OR 1.32, CI 1.15-1.52, p < 0.001). Among participants, only 22.9% were willing to participate in clinical trials of the booster dose of COVID-19 vaccine. The biggest motivator for participation was the participants' desire to help find the best vaccine during pregnancy/lactation (57.5%) while the main barrier towards participation was not wanting to expose themselves and their babies to more side effects (88.0%).Conclusion: This study reported reasonable acceptance of vaccination in a sample of pregnant/lactating women. Vaccination hesitancy for the booster dose was in-line with similar studies on the primary series around the globe, but the willingness to participate in clinical trials was lower than non-pregnant/nonlactating women.

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Section: Discussionmentioning

confidence: 99%

Mothers’ Impressions and Beliefs About Taking a Booster Dose for COVID-19 Vaccine During Pregnancy and Lactation

Taybeh¹,

Alsharedeh²,

Hamadneh³

2022

Cureus

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“…Excluding pregnant patients from research has the potential for this population to not gain the benefits associated with medical advances. 14 Unfortunately, many providers both outside and inside of obstetrics believe that clinical trials involving pregnant women are not possible or are exceedingly difficult. In contrast to the notion, discussion has recently moved toward the prioritization of research in the field of obstetrics in order to optimize outcomes and ultimately protect pregnant patients.…”

Section: Forward Movementmentioning

confidence: 99%

Maternal mortality in the United States: The pervasive effects of racism

Bisson

Dautel

Patel

et al. 2022

Med

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“…Notwithstanding valid concerns regarding fetal and infant safety, an outright exclusionary response to this complex issue has denied the maternal–fetal/infant dyad the health benefits of biomedical innovation, despite demonstrated public health need [ 2 , 3 ]. As a recent example, during the COVID-19 pandemic, pregnant women and people were excluded from early therapeutic and vaccine trials despite greater severity of infection-related illness [ 4 – 9 ].…”

Section: Introductionmentioning

confidence: 99%

“…Notwithstanding valid concerns regarding fetal and infant safety, an outright exclusionary response to this complex issue has denied the maternal-fetal/infant dyad the health benefits of biomedical innovation, despite demonstrated public health need [2,3]. As a recent example, during the COVID-19 pandemic, pregnant women and people were excluded from early therapeutic and vaccine trials despite greater severity of infection-related illness [4][5][6][7][8][9]. Including pregnant and lactating women and people as research participants is vital: pregnancy is a unique physiological state where the body undergoes adaptations that can lead to pregnancy-specific disorders or worsen preexisting conditions [10].…”

Section: Introductionmentioning

confidence: 99%

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

Shankar,

Hazfiarini,

Zahroh

et al. 2024

PLoS Med

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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.

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Advancing research in pregnancy during COVID-19: Missed opportunities and momentum in the US

Cited by 4 publications

References 14 publications

Mothers’ Impressions and Beliefs About Taking a Booster Dose for COVID-19 Vaccine During Pregnancy and Lactation

Mothers’ Impressions and Beliefs About Taking a Booster Dose for COVID-19 Vaccine During Pregnancy and Lactation

Maternal mortality in the United States: The pervasive effects of racism

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

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