Clinical trial NCT06587373: Impact of Traumatic Childbirth on Mother-baby Dyadic Interaction and Maternal Psychological Outcome: a Prospective Study
Official title: Impact of Traumatic Childbirth on Mother-baby Dyadic Interaction and Maternal Psychological Outcome: a Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parturition Complication
Keywords: MOTHER-BABY DYADIC INTERACTION
MATERNAL PSYCHOLOGICAL MENTAL HEALTH
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women from the TOPASE study, having obtained a QEVA and/or QETRAS score either ≤ the first quartile (traumatic childbirth group) or ≥ the third quartile (non-traumatic childbirth group) will be contacted in random order (a random draw using R software until the desired number of women is obtained) at 15 months (+/-3 months) after delivery by a midwife from the gynecology-obstetrics department in order to propose participation in the study

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Concerning the mother :

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of mother-baby dyadic interactions assessed by Coding Interactive Behavior
timeFrame: 15 months (+/- 3 months) postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
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