NCT06204757

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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

December 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

December 15, 2023

Last Update Submit

September 10, 2024

Conditions

Keywords

traumadeliverychildbirthquestionary

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

Other: questionary

midwives

Other: questionary

Interventions

questionary relating to birth trauma are completed by midwives and patients

midwiveswomen

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

Wounds and Injuries

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

Locations