NCT06587373

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Jul 2026

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

September 3, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

MOTHER-BABY DYADIC INTERACTIONMATERNAL PSYCHOLOGICAL MENTAL HEALTH

Outcome Measures

Primary Outcomes (1)

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

    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).

    15 months (+/- 3 months) postpartum

Study Arms (2)

traumatic childbirth

Other: Assessment of the quality of mother-child dyadic relationships

non traumatic childbirth

Other: Assessment of the quality of mother-child dyadic relationships

Interventions

Filling out questionnaires

non traumatic childbirthtraumatic childbirth

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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 :
  • No opposition from holders of parental authority
  • Child with organic malformation and/or objectified genetic anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 2530, France

Location

Related Publications (1)

  • 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 recommendations for future research. Journal of Psychosomatic Obstetrics and Gynaecology, 29(4), 240-250. https://doi.org/10.1080/01674820802034631 Berger, M., Castellani, C., Ninoreille, K., Basset, T., Frere-Meusnier, D., & Rigaud, C. (2010). Stress dus aux traumatismes relationnels précoces: Conséquences cérébrales de la perturbation de la sécrétion du cortisol sanguin chez les nourrissons. Neuropsychologie, 58(5), 282-292. https://doi.org/10.1016/j.neurenf.2009.09.003 Brockington, I. F., Oates, J., George, S., Turner, D., Vostanis, P., Sullivan, M., Loh, C., & Murdoch, C. (2001). A Screening Questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health, 3(4), 133-140. https://doi.org/10.1007/s007370170010 Chabbert, M., & Wendland, J. (2016). Le vécu de l'accouchement et le sentiment de contrôle perçu par la femme lors du travail: Un impact sur les relations précoces mère-bébé ? Revue de Médecine Périnatale, 8(4), 199-206. https://doi.org/10.1007/s12611-016-0380-x Chasson, M., & Taubman - Ben-Ari, O. (2023). The Maternal Disintegrative Responses Scale (MDRS): Development and initial validation. Journal of Clinical Psychology, 79(2), 415-430. https://doi.org/10.1002/jclp.23414 Cox, J. L., Chapman, G., Murray, D., & Jones, P. (1996). Validation of the Edinburgh Postnatal Depression Scale (EPDS) in non-postnatal women. Journal of Affective Disorders, 39(3), 185-189. Cox, J. L., Murray, D., & Chapman, G. (1993). A Controlled Study of the Onset, Duration and Prevalence of Postnatal Depression. British Journal of Psychiatry, 163(1), 27-31. https://doi.org/10.1192/bjp.163.1.27 Davies, J., Slade, P., Wright, I., & Stewart, P. (2008). Posttraumatic stress symptoms following childbirth and mothers' perceptions of their infants. Infant Mental Health Journal, 29(6), 537-554. https://doi.org/10.1002/imhj.20197 Dekel, S., Ein-Dor, T., Dishy, G. A., & Mayopoulos, P. A. (2020). Beyond postpartum depression: Posttraumatic stress-depressive response following childbirth. Archives of Women's Mental Health, 23(4), 557-564. https://doi.org/10.1007/s00737-019-01006-x Dekel, S., Stuebe, C., & Dishy, G. (2017). Childbirth Induced Posttraumatic Stress Syndrome: A Systematic Review of Prevalence and Risk Factors. Frontiers in Psychology, 8, 560. https://doi.org/10.3389/fpsyg.2017.00560 Diagnostic and statistical manual of mental disorders: DSM-5TM, 5th ed. (pp. xliv, 947). (2013). American Psychiatric Publishing, Inc. https://doi.org/10.1176/appi.books.9780890425596 Ertan, D., Hingray, C., Burlacu, E., Sterlé, A., & El-Hage, W. (2021). Post-traumatic stress disorder following childbirth. BMC Psychiatry, 21(1), 155. https://doi.org/10.1186/s12888-021-03158-6 Feldman, R. (1998). Coding interactive behavior manual. Unpublished Manual. Ferber, S. G., Feldman, R., Kohelet, D., Kuint, J., Dollberg, S., Arbel, E., & Weller, A. (2005). Massage therapy facilitates mother-infant interaction in premature infants. Infant Behavior and Development, 28(1), 74-81. https://doi.org/10.1016/j.infbeh.2004.07.004 Fournier, A., & Bérubé, A. (2018). La qualité de l'interaction mère-enfant et le rôle du cortisol: Portrait d'une population vivant en contexte de vulnérabilité. Frankham, L. J., Thorsteinsson, E. B., & Bartik, W. (2023). Birth related PTSD and its association with the mother-infant relationship: A meta-analysis. Sexual & Reproductive Healthcare, 38, 100920. https://doi.org/10.1016/j.srhc.2023.100920 Garthus-Niegel, S., Horsch, A., Handtke, E., von Soest, T., Ayers, S., Weidner, K., & Eberhard-Gran, M. (2018). The Impact of Postpartum Posttraumatic Stress and Depression Symptoms on Couples' Relationship Satisfaction: A Population-Based Prospective Study. Frontiers in Psychology, 9, 1728. https://doi.org/10.3389/fpsyg.2018.01728 Guedeney, A., & Tereno, S. (2012). La vidéo dans l'observation d'évaluation et d'intervention en santé mentale du jeune enfant: Un outil pour la transmission. Transmission - Strasbourg 2010 - Seconde Partie, 60(4), 261-266. https://doi.org/10.1016/j.neurenf.2011.12.001

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

dyadic hair cortisol

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

January 2, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations