TraumaTOPASENCT06204757
Study of the Identification of Childbirth Trauma in the Birth Room by Midwives.
An observational study of Trauma and Childbirth Problems, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trauma, Childbirth Problems
- What is being tested?
- questionary
- How many people
- 1,440 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 30 Sep 2024
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. women who gave birth to a healthy baby 2. gynecological department midwife
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Trauma, Childbirth Problems
- Being tested
- questionary
- Keywords
- trauma, delivery, childbirth, questionary
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaryOther
questionary relating to birth trauma are completed by midwives and patients
| Study group | Role | What they receive |
|---|---|---|
| women | women who have given birth to a healthy baby Receives: Other: questionary | |
| midwives | Not described Receives: Other: questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 12 hours of delivery.
Secondary outcomes (2)
Describe women's experiences of childbirth as measured by overall score on the QEVA self-questionnaire.
Using Childbirth assessment self-questionnaire (QEVA self-questionnaire).
Measured: 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
Using Peri-traumatic distress inventory
Measured: Between days 1 and 6 post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204757
- Sponsor's protocol ID
- 2023/838
- Acronym
- TOPASE
- Status last verified
- Sep 2024
- First submitted
- 15 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Identification of Childbirth Trauma in the Birth Room by Midwives.
- ClinicalTrials.gov ID
- NCT06204757
- Acronym / sponsor ID
- TOPASE / 2023/838
- Conditions
- Trauma, Childbirth Problems
- Keywords
- trauma, delivery, childbirth, questionary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women | – | Other: questionarywomen who have given birth to a healthy baby |
| midwives | – | Other: questionary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. women who gave birth to a healthy baby 2. gynecological department midwife
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionaryquestionary relating to birth trauma are completed by midwives and patients | Other | midwives, women |
Primary outcome
Evaluation of midwives' perception of traumatic deliveries in relation to obstetrical data
Time frame: within 12 hours of delivery.
Using the Midwifery Trauma Assessment Questionnaire (QETRAS questionnaire) filled in by the midwife (who witnessed the child's expulsion) within 12 hours of delivery.
2 secondary outcomes
Describe women's experiences of childbirth as measured by overall score on the QEVA self-questionnaire.
Time frame: 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
Time frame: Between days 1 and 6 post-delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Childbirth Problems, 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 4 inclusion and 6 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of midwives' perception of traumatic deliveries in relation to obstetrical data (time frame: within 12 hours of delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.