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Not yet recruiting NCT06587373

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

Observational Parturition Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of the quality of mother-child dyadic relationships.
Who it may be relevant to
Registry conditions: Parturition Complication. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Assessment of the quality of mother-child dyadic relationships
    Filling out questionnaires

Primary outcome measures

  • Quality of mother-baby dyadic interactions assessed by Coding Interactive Behavior [Time frame: 15 months (+/- 3 months) postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • CHU de Besançon — Besançon

Publications

  • Ayers, S., Eagle, A., & Waring, H. (2006). The effects of childbirth-related post-traumatic stress disorder on women and their relationships: A qualitative study. Psychology, Health & Medicine, 11(4), 389-398. https://doi.org/10.1080/13548500600708409 Ayers, S., Joseph, S., McKenzie-McHarg, K., Slade, P., & Wijma, K. (2008). Post-traumatic stress disorder following childbirth: Current issues and r

Identifiers

NCT: NCT06587373 · 2024/898

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗