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临床试验/NCT06587373
NCT06587373尚未招募不适用

Impact of Traumatic Childbirth on Mother-baby Dyadic Interaction and Maternal Psychological Outcome: a Prospective Study

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Quality of mother-baby dyadic interactions assessed by Coding Interactive Behavior

研究概览

简要总结

While a significant percentage of women in France have difficult pregnancies and negative childbirth experiences, there is still lack of documentation on the impact of these traumatic experiences on maternal health and mother-child relationships. Few studies have focused on the mental health of mothers, despite traumatic experiences being a risk factor for post-traumatic stress, depressive disorders, and suicide. The findings also highlights the maternal withdrawals and intrusions in interaction with the child, which are associated with guilt and feelings of helplessness, a risk to the emotional regulation of the child. Additionally, avoidance symptoms resulting from traumatic experiences delay mothers' seeking help and the early management of dysfunctional interactions. Therefore, assessing the mother-child interactions is important in understanding perinatal psychopathology.

详细描述

The population include the mother-infant dyads participated in the previous study TOPASE).

The study population comprises 2 groups: a group of women who have experienced a traumatic birth and/or a birth perceived as traumatic by the midwives, and a group of women who have experienced a non-traumatic birth and/or a birth perceived as non-traumatic by the midwives.

The aim of this study is to analyze the impact of traumatic childbirth on the quality of mother-baby dyadic interaction and describe the impact of traumatic childbirth on the mother's mental health and the child's psychomotor and social-emotional development.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who participated in the TOPASE study
  • Non-opposition indicating that the subject agrees to participate in the study and to abide by the requirements and restrictions inherent to this study (including hair sampling for mother and child)
  • Affiliation with a French social security scheme or beneficiary of such a scheme
  • Women belonging to the "Traumatic delivery" group: QEVA and/or QETRAS score less than or equal to the first quartile
  • Women belonging to the "Non-traumatic delivery" group: QEVA and/or QETRAS score greater than or equal to the third quartile

排除标准

  • Persons deprived of their liberty by a judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social establishment for purposes other than research.
  • adults under legal protection or unable to express their consent
  • Subjects in the exclusion period of another study or in the "national volunteer file".
  • Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
  • Refusal to take hair samples from the dyad
  • Refusal of video recording of dyad
  • Language barrier preventing understanding of instructions
  • Cognitive impairment preventing understanding of study instructions
  • Women whose child had been hospitalized in intensive care for more than a week or had died
  • Concerning the child :
  • Inclusion Criteria:
  • No opposition from holders of parental authority
  • Exclusion Criteria:
  • Child with organic malformation and/or objectified genetic anomaly

结局指标

主要结局

Quality of mother-baby dyadic interactions assessed by Coding Interactive Behavior

时间窗: 15 months (+/- 3 months) postpartum

Assessed by Coding Interactive Behavior subscores: * dyadic reciprocity * mother-infant avoidance * mother and child engagement The rating grid includes 43 items: 22 for the adult, 16 for the child and 5 for the dyad. The rating is carried out after observing the entire sequence and reflects the observer's judgment taking into account the relative levels of specific behaviors, the nature of affective/attentional states, reciprocity and adaptation of partners in the interaction between them. For each item, the clinician assigns a score between 1 and 5 (level 1 being a low occurrence of a behavior or emotion and 5 a high level of appearance of the characteristic of the element in the interaction).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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