Study of the Identification of Childbirth Trauma in the Birth Room by Midwives.
TOPASE
1 other identifier
observational
1,440
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
December 15, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedSeptember 19, 2024
September 1, 2024
6 months
December 15, 2023
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Describe women's experiences of childbirth as measured by overall score on the QEVA self-questionnaire.
Between days 1 and 6 post-delivery
Describe women's experiences of childbirth as measured by Peri-traumatic distress inventory.Overall score on the PDI inventory
Between days 1 and 6 post-delivery
Study Arms (2)
women
women who have given birth to a healthy baby
midwives
Interventions
questionary relating to birth trauma are completed by midwives and patients
Eligibility Criteria
1. women who gave birth to a healthy baby 2. gynecological department midwife
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Besançon
Besançon, France
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2023
First Posted
January 12, 2024
Study Start
January 1, 2024
Primary Completion
June 30, 2024
Study Completion
September 30, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share