Qualitative interview study exploring the perspectives of pregnant women on participating in controlled human infection research in the UK

Abstract

IntroductionPregnant women have been historically excluded from interventional research. While recent efforts have been made to improve their involvement, there remains a disparity in the evidence base for treatments available to pregnant women compared with the non-pregnant population. A significant barrier to the enrolment of pregnant women within research is risk perception and a poor understanding of decision-making in this population.ObjectiveAssess the risk perception and influences on decision-making in pregnant women, when considering whether to enrol in a hypothetical interventional research study.DesignSemistructured interviews were undertaken, and thematic analysis was undertaken of participant responses.ParticipantsTwelve pregnant women were enrolled from an antenatal outpatient clinic.ResultsParticipants were unanimously positive about enrolling in the proposed hypothetical interventional study. Risk perception was influenced by potential risks to their fetus and their previous experiences of healthcare and research. Participants found the uncertainty in quantifying risk for new research interventions challenging. They were motivated to enrol in research by altruism and found less invasive research interventions more tolerable.ConclusionIt is vital to understand how pregnant women balance the perceived risks and benefits of interventional research. This may help clinicians and scientists better communicate risk to pregnant women and address the ongoing under-representation of pregnant women in interventional research.

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

“… b One study conducted in low- and high-income countries [ 85 ], and 1 study conducted in low- and middle-income countries [ 78 ]. c Eight studies address 2 trial areas [ 40 , 41 , 45 , 46 , 48 , 60 , 85 , 94 ]. d Twenty-nine papers reported more than 1 participant group [ 43 – 45 , 47 , 51 , 53 – 55 , 57 , 61 , 62 , 64 – 67 , 71 , 73 , 74 , 82 , 85 – 87 , 89 – 91 , 94 – 97 ].…”

“…Thirty-nine papers used qualitative methodologies [ 39 , 40 , 42 – 48 , 53 , 54 , 56 – 66 , 69 , 70 , 72 – 74 , 78 , 81 , 82 , 84 – 87 , 89 – 92 , 96 ], 18 papers used quantitative methodologies [ 38 , 41 , 50 – 52 , 67 , 68 , 71 , 75 – 77 , 79 , 80 , 88 , 93 – 95 , 97 ], and 3 papers used mixed-methods study designs [ 49 , 55 , 83 ].…”

“…The 60 papers present data from 27 countries and 4 geographic regions: 13 countries in Africa [ 44 – 47 , 65 , 73 , 78 , 84 , 85 ], 8 countries in Europe [ 38 , 39 , 41 , 48 – 50 , 53 – 56 , 58 , 59 , 61 , 62 , 64 , 67 – 69 , 72 , 74 , 80 – 83 , 86 , 89 , 90 , 92 , 94 , 96 ], 3 countries in the Americas [ 42 , 43 , 51 , 52 , 57 , 60 , 63 , 66 , 70 , 71 , 75 , 77 , 79 , 85 , 88 , 91 , 93 , 95 ], and 3 countries in the Western Pacific [ 40 , 76 , 87 , 97 ].…”

“…Twenty-five papers included perspectives of pregnant women [ 38 , 45 , 47 , 48 , 51 , 57 , 58 , 60 , 61 , 64 , 65 , 67 , 71 – 75 , 77 , 85 , 89 – 91 , 94 , 95 , 97 ], 28 papers included perspectives of postpartum women [ 39 – 41 , 44 – 46 , 49 , 51 , 56 , 57 , 59 , 62 , 63 , 69 – 71 , 74 , 79 – 87 , 92 , 95 ], and 14 papers included health workers’ perspectives [ 44 , 47 , 50 , 52 – 54 , 61 , 64 , 65 , 67 , 87 , 88 , 91 , 94 ]. For other stakeholder groups, please refer to Table 1 .…”

“…Perception of risks influenced pregnant and lactating women’s willingness to participate in trials, which varied based on their individual levels of risk tolerance, previous trial experiences, observations of others’ experiences, stage of pregnancy or lactation, existing health conditions, and a sense of responsibility for their health and that of the fetus/infant. Women were more likely to decline participation if the experimental intervention was previously untested and were more confident to participate when convinced of no harm (high confidence) [ 39 , 40 , 47 , 48 , 57 , 58 , 60 , 63 – 65 , 69 , 72 , 74 , 83 , 84 , 87 , 89 , 91 , 92 , 96 ].…”