目的:作为FERN可行性研究的一部分,这项定性研究旨在探索父母和临床医生对可接受性的看法,一项随机对照试验(RCT)的可行性和设计,在单绒毛膜(MC)双胎妊娠合并早发型(24周前)选择性胎儿生长受限(sFGR)中,积极干预与期待治疗的比较.干预措施可能包括激光治疗或选择性终止,这可能导致一个或两个双胞胎死亡或严重残疾。
方法:对父母和临床医生进行定性半结构化访谈。使用反身主题分析对数据进行了分析,并根据生物医学伦理学原则进行了考虑。
方法:我们采访了19位英国父母(六位母亲,两个伴侣)或最近经历过(八个母亲,三名合作伙伴)MC双胎妊娠的早发性sFGR和来自英国和欧洲的14名专科临床医生。
结果:参与者认为拟议的RCT是“道德模糊”,因为他们认为MC双胎妊娠sFGR的管理应根据sFGR的类型和严重程度进行个体化。临床医生优先考虑胎龄,尺寸,生长速度降低,对胎盘血管的访问和父母干预的可接受性。关于选择性终止的讨论和决策似乎会造成长期伤害(恶意)。对于父母和临床医生来说,最重要的结果是“活产”。对于临床医生来说,这是至少一个双胞胎的活产。对于父母来说,这意味着两个双胞胎的活产,即使这意味着他们的婴儿有神经发育障碍或残疾。
结论:MC双胎妊娠sFGR的所有三种妊娠管理方法都有风险和益处,父母的最终目标是接受个性化护理,以实现两个双胞胎的最佳结果。RCT对于父母或临床医生来说是不可接受的,或者在道德上是合适的。应该考虑替代研究设计来回答这个重要的研究问题。
OBJECTIVE: As part of the FERN feasibility study, this qualitative research aimed to explore parents\' and clinicians\' views on the acceptability, feasibility and design of a randomised controlled trial (RCT) of active intervention versus expectant management in monochorionic (MC) diamniotic twin pregnancies with early-onset (prior to 24 weeks) selective fetal growth restriction (sFGR). Interventions could include laser treatment or selective termination which could lead to the death or serious disability of one or both twins.
METHODS: Qualitative semi-structured interviews with parents and clinicians. Data were analysed using reflexive thematic analysis and considered against the Principles of Biomedical Ethics.
METHODS: We interviewed 19 UK parents experiencing (six mothers, two partners) or had recently experienced (eight mothers, three partners) early-onset sFGR in MC twin pregnancy and 14 specialist clinicians from the UK and Europe.
RESULTS: Participants viewed the proposed RCT as \'ethically murky\' because they believed that the management of sFGR in MC twin pregnancy should be individualised according to the type and severity of sFGR. Clinicians prioritised the gestational age, size, decrease in growth velocity, access to the placental vessels and acceptability of intervention for parents. Discussions and decision-making about selective termination appeared to cause long-term harm (maleficence). The most important outcome for parents and clinicians was \'live birth\'. For clinicians, this was the live birth of at least one twin. For parents, this meant the live birth of both twins, even if this meant that their babies had neurodevelopmental impairment or disabilities.
CONCLUSIONS: All three pregnancy management approaches for sFGR in MC twin pregnancy carry risks and benefits, and the ultimate goal for parents is to receive individualised care to achieve the best possible outcome for both twins. An RCT was not acceptable to parents or clinicians or seen as ethically appropriate. Alternative study designs should be considered to answer this important research question.