Status:
NOT_YET_RECRUITING
Impact of Traumatic Childbirth on Mother-baby Dyadic Interaction and Maternal Psychological Outcome: a Prospective Study
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Parturition Complication
Eligibility:
FEMALE
18+ years
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 m...
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 bi...
Eligibility Criteria
Inclusion
- Concerning the mother :
- 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
- 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
Key Trial Info
Start Date :
January 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06587373
Start Date
January 2 2025
End Date
July 31 2026
Last Update
September 19 2024
Active Locations (1)
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1
CHU de Besançon
Besançon, France, 2530