Impact of Traumatic Childbirth on Mother-baby Dyadic Interaction and Maternal Psychological Outco… (NCT06587373) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Traumatic Childbirth on Mother-baby Dyadic Interaction and Maternal Psychological Outcome: a Prospective Study
France60 participantsStarted 2025-01-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of mother-baby dyadic interactions assessed by Coding Interactive Behavior
Timeframe: 15 months (+/- 3 months) postpartum
Trial details
NCT IDNCT06587373
SponsorCentre Hospitalier Universitaire de Besancon