Decision-making Process of Couples Confronted With Prenatal Diagnosis of an Isolated CCA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- By using an inductive methodology, the factors (conscious and unconscious) involved in decision-making in couples regarding the outcome of pregnancy in the context of prenatal isolated CCA diagnosis will be determinated.
研究概览
简要总结
This research promoted by the AP-HP (DRCI) is financed by the Agence de la biomédecine (ABM) and the Fondation Maladie Rare (FMR) and received a favourable opinion from the CPP on 8/12/2020. It aims to describe the decision-making process of couples faced with the discovery of an isolated corpus callosum anomaly in their fetus during pregnancy. Indeed, the anomaly of the corpus callosum in antenatal represents a paradigmatic situation of the clinic of uncertainty for couples and teams, because the prognosis is variable, in 80% of the cases it is favourable and in 20% it is associated with an intellectual deficiency. This study will use a mixed methodology, combining quantitative data (STAI A and B anxiety scale, BDI-II depression scale, PCL-5 post-traumatic stress scale, DAS-16 marital relationship dynamics scale, experimental emotional self-evaluation scales adapted to each member of the couple, R/S scale) and qualitative data (through a research interview of the couple conducted by a research psychologist). In the course of the study, 50 couples will be interviewed between 3 months and 5 years after the pregnancy (post-medical termination of pregnancy and post-delivery), with 25 couples who will have continued the pregnancy and 25 couples who will have terminated the pregnancy. Statistical and qualitative analysis of the data using NVivo software will be performed. The aim is to better understand the factors that lead couples to decide to continue or terminate a pregnancy in a situation of extreme prognostic uncertainty, their experience of their decision and to improve the care pathway currently offered to these couples faced with this type of situation.
详细描述
Couples facing with the discovery of fetal isolated CCA during pregnancy find themselves in a paradigmatic situation of decision-making in a context of extreme uncertainty. They must decide whether to continue or to terminate the pregnancy based on statistical probabilities regarding neurodevelopmental prognosis: favourable in about 80% of cases and associated with an intellectual disability (ID) in about 20% of cases, of variable severity (5% severe). This complex decision belongs to each couple. In situations of prenatal diagnosis it is currently known that the predominant factors in decision-making are related to medical information and to subjective parental perception of the consequences of this information (the potential suffering of the child, the impact on family life, the quality of life of the child, etc.). Prognosis' uncertainty complicates this decision-making and brings couples into significant distress which they express in consultation.
How do couples make their decision? How do they experience this decision over time? These questions have not yet been the subject of a specific study concerning decision-making in a context of an uncertain prognosis. It seems essential to better identify the decision-making mechanisms at stake and to understand the experience of this decision-making over time. Findings of this study could improve current practices in support of concerned couples.
More broadly, given the global development of technological advances in prenatal diagnosis (particularly in imaging and genetics), couples are and will increasingly be facing situations of high prognostic uncertainty. A better understanding of the decision-making process concerning the outcome of pregnancy seems essential, as well as the psychological impact of this decision - whatever it may be - on couples. The conclusions of this study, focused on a paradigmatic situation, could be applied to others. Rooted in an interdisciplinary approach, it is crucial that the teams question their practice to improve couples' support during and after pregnancy in all disciplines involved. Finally, technological progress leads to questions that raise ethical and societal issues. This study may provide possible methods ways of response. The main objective of this research is to study the conscious and unconscious factors involved in the couples' decision-making process regarding the outcome of pregnancy in the context of prenatal diagnosis of isolated CCA. Moreover, the investigators aim to study the couples' experiences concerning their decision to continue or terminate the pregnancy and the psychological impact of this decision. The investigators want to evaluate the impact of time on the experience of their decision. The investigators expect to identify the needs of the people involved in order to re-evaluate the practices and improve the care pathway currently proposed.
The study population includes couples who had a fetal announcement of isolated CCA during pregnancy. Both members are 18 years of age or older benefiting from the social security system. They will be included in the study from 3 months to 5 years after the end of the pregnancy (delivery or termination). Signed informed and free consent for each individual is obtained.
Couples for whom a new pregnancy is in progress, one of whose members does not speak French and/or is under legal protection and/or is under a security measure and/or suffers from a decompensated psychiatric pathology known at the time of recruitment cannot be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Couples of which the 2 members are aged 18 and over
- •Couples who have been notified of a fetal isolated CCA
- •Inclusion in the study 3 months to 5 years after the end of pregnancy (delivery or IMG)
- •Collection of free, informed and written consent from each of the 2 members of the couple for their participation in research
- •2 members of the couple beneficiaries of a social security scheme (beneficiary or entitled outside AME)
排除标准
- •Couples of which one member does not speak French
- •Couples in which one of the members suffers from a decompensated psychiatric pathology known at the time of recruitment
- •Couples for whom a new pregnancy is in progress
- •Couples in which one of the members is under legal protection measure or under security measure.
结局指标
主要结局
By using an inductive methodology, the factors (conscious and unconscious) involved in decision-making in couples regarding the outcome of pregnancy in the context of prenatal isolated CCA diagnosis will be determinated.
时间窗: During the one research interview at the inclusion visit
Explored in the interview : * The development of the child perceived by the parents * The subjective risk of disability linked to an isolated CCA * Representations of disability in general, preexisting in pregnancy * The history of pregnancy before the discovery of the fetal abnormality: experience of the pregnancy since its confirmation and until the discovery of the anomaly, perceptions and representations around the fetus-baby, positive or negative events concerning pregnancy * Family support: do couples feel supported by their families? did they perceive an agreement or disagreement as to their decision * Discourse and medical attitudes perceived by couples towards the possibilities of TOP or prosecution The interviews are audio registered and fully transcripted. Afterwards they will be analysed through a thematic analysis, in support of NVivo Software. This metodology will give access to qualitative and quantitive datas of the interview.
次要结局
- Evaluate the conjugal factors(This other outcome will be assess at the inclusion visit)
- Evaluate the anxiety within the couples of the study(This other outcome will be assess at the inclusion visit)
- Describe the needs of the couples(This other outcome will be assess at the inclusion visit)
- Study the traumatic impact of the decision(This secondary outcome will be assess at the inclusion visit)
- Evaluate the depression within the couples of the study(This other outcome will be assess at the inclusion visit)
- Evaluate the degree of confidence in the decision(This other outcome will be assess at the inclusion visit)