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NCT Number: NCT06587373

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

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.

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Key information

Conditions

Parturition Complication

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Besançon

Besançon, 2530, France

Location contact

Lauriane Vulliez-Coady, Pr

PRINCIPAL_INVESTIGATOR

Monika Szymanska

CONTACT

[email protected]

+33381219352

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of the quality of mother-child dyadic relationships

Other

Filling out questionnaires

Primary outcomes

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

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

astrid POZET

CONTACT

[email protected]

33381218988

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: TOPASE+

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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