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Parturition ComplicationTOPASE+NCT06587373

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

An observational study of Parturition Complication, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Parturition Complication
What is being tested?
Assessment of the quality of mother-child dyadic relationships
How many people
60 participants
Where
1 siteFrance
Study dates
2 Jan 2025to 31 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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
  • No opposition from holders of parental authority

Who cannot join

  • 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
Show all 11Show fewer
  • 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 :
  • Child with organic malformation and/or objectified genetic anomaly

Trial locations and contacts

1 site in 1 country.

astrid POZET contact

33381218988

aopozet@chu-besancon.fr

France1 site

  • CHU de Besançon

    Besançon, 2530

    Monika Szymanska, +33381219352, mszymanska@chu-besancon.fr

    Lauriane Vulliez-Coady, Pr

Other trials in France

About this 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.

Read the 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.

Being tested
Assessment of the quality of mother-child dyadic relationships
Keywords
MOTHER-BABY DYADIC INTERACTION, MATERNAL PSYCHOLOGICAL MENTAL HEALTH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of the quality of mother-child dyadic relationshipsOther

    Filling out questionnaires

Study groups in NCT06587373
Study groupRoleWhat they receive
traumatic childbirthNot described
Receives: Other: Assessment of the quality of mother-child dyadic relationships
non traumatic childbirthNot described
Receives: Other: Assessment of the quality of mother-child dyadic relationships

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 15 months (+/- 3 months) postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start2 Jan 2025 (estimated)
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587373
Sponsor's protocol ID
2024/898
Acronym
TOPASE+
Status last verified
Sep 2024
First submitted
3 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 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

Questions about this trial

What is this clinical trial studying?

An observational study of Parturition Complication, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact astrid POZET (33381218988, aopozet@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of mother-baby dyadic interactions assessed by Coding Interactive Behavior (time frame: 15 months (+/- 3 months) postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06587373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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