In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Studying the experience of couples who have chosen fetal surgery
研究概览
简要总结
Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. This fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future.
Currently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. No qualitative study on the subject has been published to date.
详细描述
The study population corresponds to all couples who have chosen to continue the pregnancy in the face of a prenatal diagnosis of myelomeningocele in their fetus as well as to resort to in utero surgery to repair this malformation. In order to obtain the largest possible sample, the study will be offered to both couples who have had open surgery and those who have had fetoscopy.
This study aims to investigate, a posteriori, the experience of couples who have chosen fetal surgery to repair a myelomeningocele.
This is a study in clinical psychology, cross-sectional observational with an approach that will be mixed, qualitative and quantitative.
In practice, the only procedures added by the research will consist of:
- an interview between the mother of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
- an interview between the father of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
- the completion of a decision scale by each of the parents The presence of the interview with a psychologist not planned as part of the care may lead to the modification of the usual care of the parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Mothers and adult co-parents of the child with MMC operated in utero, having signed informed consent. If both members of the couple have agreed to participate, they will be received separately.
- •Mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old
- •Speaking French
- •Not presenting a severe psychiatric disorder altering the relationship with reality
- •Patient affiliated to a social security system
排除标准
- •Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study
- •Patient under State Medical Aid
研究组 & 干预措施
Parents of children operated on in utero
Semi-structured interviews with a psychologist
干预措施: Semi-structured interviews with a psychologist (Other)
结局指标
主要结局
Studying the experience of couples who have chosen fetal surgery
时间窗: up to 18 months
Semi-structured interviews with a psychologist
次要结局
- Investigate the decision-making factors that contributed to the choice of prenatal surgery(Up to 18 months)
- Evaluate the quality of the information that couples received regarding the three possibilities proposed when faced with a prenatal diagnosis of myelomeningocele(Up to 18 months)