Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.
Prof. Dr. José A Pinotti Women's Hospital, Center of Integral Services for the Health of Women (CAISM), University of Campinas (UNICAMP), Campinas, SP, Brazil.
BMC Pregnancy Childbirth. 2019 Mar 20;19(1):97. doi: 10.1186/s12884-019-2240-8.
In clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial.
The women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using thematic analysis. After the analysis categories were defined, all the answers were reviewed, categorized and grouped. A descriptive summary of the content of each category was then made.
Overall, 208 women from different geographical regions of the country agreed to participate. Four categories were identified: 1) The risk of losing the baby; 2) A previous experience of premature delivery; 3) The role of the doctor and other health professionals, and 4) The availability of quality medical care and free medication. The main reason given for agreeing to participate was to reduce the risks associated with the baby being born prematurely, particularly when the woman herself or someone close to her had already experienced premature delivery. Other reasons were having received clear guidance and explanations from the doctor regarding prematurity and about the study and being given the opportunity to receive free treatment with greater access to the public healthcare system.
The decision to participate in a clinical trial is not easy, particularly when the individual is vulnerable and in a critical situation as in the case of a pregnant woman at a high risk of delivering prematurely. Fears and uncertainties regarding the pregnancy outcome, as well as the woman's previous experiences and her awareness of the actual risks she faces will affect her decision regarding whether or not to participate. Recruitment challenges could be overcome by ensuring that the research team provides adequate information and support, thus creating a bond with participants that would foster a sense of safety and trust in the study proposals.
在临床试验中，孕妇处于潜在脆弱的地位，胎儿会接触到干预措施。本研究旨在确定导致有早产高风险的孕妇参与随机临床试验的原因。
在产后通过电话联系参加主要试验的女性，并邀请她们参加一项横断面研究，以回答开放式问卷。通过电话收集数据，并使用主题分析进行分析。在定义了分析类别后，审查、分类和分组所有答案。然后对每个类别的内容进行描述性总结。
来自该国不同地理区域的 208 名女性同意参与。确定了四个类别：1）失去婴儿的风险；2）先前有早产经历；3）医生和其他卫生专业人员的作用；4）获得高质量医疗保健和免费药物的机会。同意参与的主要原因是降低与婴儿早产相关的风险，特别是当女性自己或亲近的人已经经历过早产时。其他原因是从医生那里获得了关于早产和研究的明确指导和解释，并获得了免费治疗的机会，从而更能利用公共医疗保健系统。
参与临床试验的决定并不容易，尤其是当个体处于脆弱和关键状态时，如有早产高风险的孕妇。对妊娠结局的担忧和不确定性，以及女性的先前经历和她对自己所面临实际风险的认识，将影响她是否参与的决定。通过确保研究团队提供充分的信息和支持，可以克服招募挑战，从而与参与者建立联系，培养对研究提案的安全感和信任感。
