Study of the Identification of Childbirth Trauma in the Birth Room by Midwives.

Trauma Clinical Trial

— TOPASE  

Official title:

Study of the Identification of Childbirth Trauma in the Birth Room by Midwives.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06204757
• Other study ID #: 2023/838
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Monika SZYMANSKA, PhD
• Phone: +33381219352
• Email: mszymanska[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Childbirth is a critical moment in this perinatal period, with high unpredictability and risks of medical complications for the mother and child. It can be experienced as a traumatic experience for the woman. The consequences of a traumatic childbirth are numerous: psychiatric consequences for the mother: with increased risk of post-traumatic stress syndrome of postpartum depression decompensation of an old psychiatric illness, suicide , addictive disorders ; consequences on interactions: early mother-baby interactions are of poorer quality if the women have a negative experience of their birth. Very few studies have focused on the early detection of traumatic childbirth, on the day of it. These evaluations only take into account the women's experience of their childbirth. The systematization of a screening questionnaire for all deliveries would help to detect obvious traumatic deliveries but also to detect traumatic experiences when objectively the delivery occurs without obstetric complications. This is why the objective of our study is to evaluate the perception of traumatic births by midwives.

Description:

In a woman's life, the perinatal period is a phase of vulnerability, at risk of psychiatric complications: risk of decompensation of an existing psychiatric illness (depression, bipolar disorder, psychosis, anxiety disorder) and triggering of a pathology de novo. Childbirth is a critical moment in this perinatal period, with high unpredictability and risks of medical complications for the mother and child. It can be experienced as a traumatic experience for the woman. In France, 16.7% of women present major depressive symptoms 2 months after giving birth (National Institute of Health and Medical Research, 2021). Suicide is one of the two leading causes of maternal mortality up to 1 year postpartum, with approximately 1 suicide per month (approximately 13.4% of maternal deaths), the vast majority of which (91.3%) is considered potentially preventable (National Institute of Health and Medical Research, 2021b). The data in the literature are still insufficient and lacking in homogeneity. Among the most relevant, an Australian study from 2014 found a traumatic childbirth experience in 14.3% of women (890 completed questionnaires) (Boorman et al., 2014). In recent studies, the rate of negative childbirth experiences ranges from 5 to 21% of women (Henriksen et al., 2017; Nystedt & Hildingsson, 2018; Sigurdardottir et al., 2017; Smarandache et al., 2016 ). The consequences of a traumatic childbirth are numerous: - Psychiatric consequences for the mother: with increased risk of post-traumatic stress syndrome of postpartum depression decompensation of an old psychiatric illness, suicide (National Institute of Health and Medical Research, 2021a; Orsolini et al., 2016), addictive disorders. - Consequences on interactions: early mother-baby interactions (first 4 months postpartum) are of poorer quality if the women have a negative experience of their birth. Traumatic childbirth has long-term repercussions on identity, relationships with others, and adherence to care with more medical wandering. It is therefore important to treat the trauma of childbirth early to reduce the severity and duration of its complications (Marianne Kédia & Sabouraud-Séguin, 2020). If it is not identified in the maternity ward, women will often not talk about the trauma, or will talk about it after their next pregnancy. As mentioned above, the risk of depression and suicide is higher. If it is identified on the day of the trauma, psychological or psychiatric support can be started during the stay in the maternity ward, by sharing this experience recognized by the healthcare teams. A single debriefing interview after a trauma is not enough to reduce the risk of complications but allows an alliance to be established to implement care (Sabouraud-Séguin, 2020). The recognition of traumatic childbirth is recent, and teams are still insufficiently aware of the consequences, and poorly trained in the systematization of recommendations. Screening for traumatic childbirth should be carried out throughout the perinatal period. Before childbirth: during pregnancy monitoring, caregivers identify patients with vulnerabilities such as a history of trauma, complicated deliveries, or vulnerability. These women will be more at risk of having a negative experience of their childbirth (Ayers et al., 2016). In the delivery room: the teams identify obstetric situations at risk of trauma (instrument, cesarean section, somatic complications for the mother such as hemorrhages, and somatic complications for the child such as situations requiring neonatal resuscitation), and observe the reactions of the patient. During the stay in the maternity ward: the teams question the mothers' experience of childbirth, observe their behavior and first interactions. Symptoms that are part of the state of acute stress should alert you: intrusive symptoms, negative mood, dissociative symptoms, avoidance symptoms and arousal symptoms (American Psychiatric Association et al., 2015). After leaving the maternity ward, the woman has numerous follow-up appointments for herself and her baby, including the post-natal appointment. These moments of discussion are key moments for screening for traumatic symptoms (acute stress and post-traumatic stress syndrome) and depressive symptoms. Very few studies have focused on the early detection of traumatic childbirth, on the day of it. These evaluations only take into account the women's experience of their childbirth. Two self-questionnaires were validated: Childbirth Experience Evaluation Questionnaire, QEVA (Carquillat et al., 2017; Chabbert et al., 2021); Peritraumatic Distress Inventory, PDI, which measures peri-traumatic distress, without being specific to an event, it is therefore not specialized for childbirth (Professional Space & Training | Info-Trauma, n.d.; Jehel et al., 2005 ). The limits linked to self-questionnaires in a traumatic context and the impact of avoidance syndrome: women who have experienced a traumatic childbirth are more likely to avoid thinking about events, places, people linked to the trauma. To our knowledge, no tool has been developed to assess the perception of traumatic births by midwives. Midwives have an essential role during childbirth, from an obstetrical point of view, but also from a psychological point of view. They are present throughout the birth (labor, expulsion, delivery) and accompany the woman through her emotions, her doubts and her requests, with a common goal: the smooth running of the birth. However, they observe the entire course of the birth, with its complications and the reactions of the women. A hetero-assessment questionnaire, so that the trauma of childbirth can be assessed by midwives without needing the woman to recount her experience, would be useful for screening. The systematization of a screening questionnaire for all deliveries would help to detect obvious traumatic deliveries (for example during code red cesarean sections) but also to detect traumatic experiences when objectively the delivery occurs without obstetric complications. In addition, the systematic questionnaire would make it possible to obtain the midwives' observations, which are not always transmitted in their entirety to the maternity team when the emotional experience has been too intense. The objective of our study is to evaluate the perception of traumatic births by midwives. The research hypothesis is that midwives can identify some indicators of birth trauma during childbirth and contribute to screening for traumatic birth.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1440
• Est. completion date: August 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women aged over 18
• Women followed after delivery in the maternity department of Besancon University Hospital
• Non-opposition indicating that the subject agrees to participate in the study and to comply with the requirements and restrictions inherent to this study
• Affiliation to a French social security scheme or beneficiary of such a scheme

Exclusion Criteria:

• Legal incapacity or limited legal capacity
• Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
• Language barrier preventing instructions from being understood
• Cognitive disorders preventing understanding of study instructions
• Subject without health insurance
• Women whose child is hospitalized in intensive care or has died

Related Conditions & MeSH terms

• Childbirth Problems
• Trauma
• Wounds and Injuries

Intervention

Other:
• questionary
questionary relating to birth trauma are completed by midwives and patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

References & Publications (1)

American Psychiatric Association, Crocq, M.-A., Guelfi, J.-D., Boyer, P., Pull, C.-B., & Pull, M.-C. (2015). DSM-5-Critères diagnostiques (5ème). Elsevier Masson. https://www.elsevier-masson.fr/dsm-5-manuel-diagnostique-et-statistique-des-troubles-mentaux-9782294739293.html Aydin, R., & Aktas, S. (2021). Midwives' experiences of traumatic births: A systematic review and meta-synthesis. European Journal of Midwifery, 5, 31. https://doi.org/10.18332/ejm/138197 Ayers, S., Bond, R., Bertullies, S., & Wijma, K. (2016). The aetiology of post-traumatic stress following childbirth: A meta-analysis and theoretical framework. Psychological Medicine, 46(6), 1121-1134. https://doi.org/10.1017/S0033291715002706 Beck, C. T., & Casavant, S. (2019). Synthesis of Mixed Research on Posttraumatic Stress Related to Traumatic Birth. Journal of Obstetric, Gynecologic, and Neonatal Nursing: JOGNN, 48(4), 385-397. https://doi.org/10.1016/j.jogn.2019.02.004 Bell, A. F., & Andersson, E. (2016). The birth experience and women's postnatal depression: A systematic review. Midwifery, 39, 112-123. https://doi.org/10.1016/j.midw.2016.04.014 Boorman, R. J., Devilly, G. J., Gamble, J., Creedy, D. K., & Fenwick, J. (2014). Childbirth and criteria for traumatic events. Midwifery, 30(2), 255-261. https://doi.org/10.1016/j.midw.2013.03.001 Carquillat, P., Vendittelli, F., Perneger, T., & Guittier, M.-J. (2017). Development of a questionnaire for assessing the childbirth experience (QACE). BMC Pregnancy and Childbirth, 17(1), 279. https://doi.org/10.1186/s12884-017-1462-x Chabbert, M., Devouche, E., Rozenberg, P., & Wendland, J. (2021). Validation de l'échelle d'évaluation du vécu de l'accouchement (QEVA) auprès d'une population française. L'Encéphale, 47(4), 326-333. https://doi.org/10.1016/j.encep.2020.06.016 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 Espace professionnel & formation | Info-Trauma. (n.d.). Retrieved 17 June 2023, from http://www.info-trauma.org/fr/formation Fenech, G., & Thomson, G. (2014). Tormented by ghosts from their past': A meta-synthesis to explore the psychosocial implications of a traumatic birth on maternal well-being. Midwifery, 30(2), 185-193. https://doi.org/10.1016/j.midw.2013.12.004 Haut Conseil à l'Égalité entre les femmes et les hommes, BOUSQUET, D., COURAUD, G., & COLLET, M. (2018). Les actes sexistes durant le suivi gynécologique et obstétrical (2018-06-26-SAN-034). https://www.haut-conseil-egalite.gouv.fr/sante-droits-sexuels-et-reproductifs/actualites/article/actes-sexistes-durant-le-suivi-gynecologique-et-obstetrical-reconnaitre-et Henriksen, L., Grimsrud, E., Schei, B., Lukasse, M., & Bidens Study Group. (2017). Factors related to a negative birth experience-A mixed methods study. Midwifery, 51, 33-39. https://doi.org/10.1016/j.midw.2017.05.004 Institut national de la santé et de la recherche médicale. (2021a). Enquête Nationale Périnatale: Les naissances, le suivi à deux mois et les établissements. Situation et évolution depuis 2016. Institut national de la santé et de la recherche médicale, S. P. F. (2021b). Les morts maternelles en France: Mieux comprendre pour mieux prévenir. 6e rapport de l'Enquête nationale confidentielle sur les morts maternelles (ENCMM) 2013-2015. Jehel, L., Brunet, A., Paterniti, S., & Guelfi, J. D. (2005). [Validation of the Peritraumatic Distress Inventory's French translation]. Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie, 50(1), 67-71. https://doi.org/10.1177/070674370505000112 Leinweber, J., Creedy, D. K., Rowe, H., & Gamble, J. (2017). Responses to birth trauma and prevalence of posttraumatic stress among Australian midwives. Women and Birth: Journal of the

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of midwives' perception of traumatic deliveries in relation to obstetrical data	Using the Midwifery Trauma Assessment Questionnaire (QETRAS questionnaire) filled in by the midwife (who witnessed the child's expulsion) within 12 hours of delivery.	within 12 hours of delivery.
Secondary	Describe women's experiences of childbirth as measured by overall score on the QEVA self-questionnaire.	Using Childbirth assessment self-questionnaire (QEVA self-questionnaire).	Between days 1 and 6 post-delivery
Secondary	Describe women's experiences of childbirth as measured by Peri-traumatic distress inventory.Overall score on the PDI inventory	Using Peri-traumatic distress inventory	Between days 1 and 6 post-delivery