AzTrials
AzTrials

Post Traumatic Stress DisorderSwiTCHNCT05865704

Childbirth-related Post-traumatic Stress Disorder in Switzerland: The Swiss Cohort on Traumatic Childbirth and Health

An observational study of Post Traumatic Stress Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

The goal of this observational study is to investigate the prevalence of Childbirth post-traumatic stress disorder (CB-PTSD) and Childbirth post-traumatic stress symptom (CB-PTSS) in Switzerland, and to analyze the psychological, medical, and social factors linked with CB-PTSD and CB-PTSS, whether they are antecedent… Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Post Traumatic Stress Disorder
How many people
1,000 participants
Where
1 siteSwitzerland
Study dates
1 May 2022to Dec 2025
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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The population speaks French since the surveys are in French. The population is recruited in the French speaking part of Switzerland (Vaud, Neuchâtel, Geneva, Friburg, Wallis) in Lausanne University Hospital, in regional hospitals, and at independant healthcare professionals (such as midwifes, gynecologist, doulas...)

Who may be able to join

  • Women being pregnant in the third pregnancy trimester, or being between 6 to 12 weeks postpartum. Partners are recruited base on the inclusion criteria for mothers.

Who cannot join

  • N/A.

Trial locations and contacts

1 site in 1 country.

Antje Horsch, Prof. contact

+41213148571

antje.horsch@chuv.ch

Switzerland1 site, 1 recruiting
  • Lausanne University Hospital

    Lausanne, Canton of Vaud, 1011

    Recruiting

Other trials in Switzerland

About this study

Official title: Childbirth-related Post-traumatic Stress Disorder in Switzerland and Understanding Its Relations With Depression, Health Care Renunciation, Coparenting and Parental Burnout: The Swiss Cohort on Traumatic Childbirth and Health

The goal of this observational study is to investigate the prevalence of Childbirth post-traumatic stress disorder (CB-PTSD) and Childbirth post-traumatic stress symptom (CB-PTSS) in Switzerland, and to analyze the psychological, medical, and social factors linked with CB-PTSD and CB-PTSS, whether they are antecedent factors or further consequences.

The main questions it aims to answer are :

Read more
  • The prevalence of CB-PTSS and CB-PTSD in Switzerland, for both mothers and partners (Primary outcome)
  • The risk and protective factors of CB-PTSD and CB-PTSS (Secondary outcome)
  • The impact of CB-PTSD and CB-PTSS on the marital and co-parental adjustment and the bonding with the infant (Secondary outcome)
  • The role of the childbirth experience on the triggering of CB-PTSD and CB-PTSS, including emotional and affective aspects (Secondary outcome)
  • The social and economic determinants of CB-PTSD and CB-PTSS, including, for example, social support and religion (Secondary outcome)

Participants will fill up surveys at four time points:

  • T1, during the third trimester of pregnancy
  • T2, at 6 to 12 weeks post-partum
  • T3, at 6 months post-partum
  • T4, at 12 months post-partum
Read the detailed description

Study design:

The present study consists of a longitudinal cohort study with surveys at four time points:

  • T1: Third trimester of pregnancy: including risk and protective factors for PTSD such as antenatal stress, mother-partner relationships, social support, current anxiety and depression, and history of mental health issues and treatments. Sociodemographic information is also collected at this time.
  • T2: 6-12 weeks postpartum: focusing on delivery conditions and its consequences with an extra focus on determining whether childbirth included eligible traumatic events such as e.g. emergency C-section, forceps, vacuum. The survey also investigates immediate PTSD onsets and other short-term outcomes such as early co-parenting quality and parent-infant bonding.
  • T3: 6 months postpartum: including reassessment of CB-PTSD since CB-PTSD occurring more than 6 months after the traumatic event represents the "delayed PTSD" subtype.
  • T4: 12 months postpartum: in order to identify the prevalence of delayed CB-PTSD, or of persistent/recurrent perinatal depression, to assess parent healthcare renunciation, as well as couple relationship quality/satisfaction and co-parenting quality.

Participants enter the SwiTCH study preferably at T1, but inclusion at T2 is also possible in order to maximize recruitment. The participants included at t2 will fill the sociodemographic and history of mental health surveys at T2 instead of T1.

Study population:

The inclusion criteria for mothers is being pregnant in the third pregnancy trimester and being above 16 years, or being between 6 to 12 weeks postpartum and above 16 years. Partners are recruited based on the inclusion criteria for mothers. Additionally, they must be 16 years old or older.

All participants are asked to sign a written consent (and if applicable, legal representatives for adolescents aged over 16 years old).

Keywords
childbirth, posttraumatic stress disorder, birth trauma
Medical subject headings
Stress Disorders, Post-Traumatic, Birth Injuries

What is being measured

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

  1. Prevalence of childbirth trauma in mother and partner

    Measure of the extent to which the birth is perceived as traumatic

    Measured: 6-12 weeks postpartum

  2. Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS)

    Childbirth-related PTSD and PTSS is assessed with the City Birth Trauma Scale (City BiTS).

    Measured: 6-12 weeks postpartum

  3. Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS)

    Childbirth-related PTSD and PTSS is assessed with the City Birth Trauma Scale (City BiTS).

    Measured: 6 months postpartum

  4. Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS)

    Childbirth-related PTSD and PTSS is assessed with the City Birth Trauma Scale (City BiTS).

    Measured: 12 months postpartum

Secondary outcomes (53)
  1. Risk factors of CB-PTSD : History of mental health issues (Mother)

    History of mental health issues/treatment, 4 items

    Measured: Baseline (Third trimester of pregnancy)

  2. Risk factors of CB-PTSD : History of mental health issues (Partner)

    History of mental health issues/treatment, 4 items

    Measured: Baseline (Third trimester of pregnancy)

  3. Risk factors of CB-PTSD : Anxiety (Mother)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: Baseline (Third trimester of pregnancy)

  4. Risk factors of CB-PTSD : Anxiety (Partner)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: Baseline (Third trimester of pregnancy)

  5. Risk factors of CB-PTSD : Depression (Mother)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: Baseline (Third trimester of pregnancy)

  6. Risk factors of CB-PTSD : Depression (Patner)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: Baseline (Third trimester of pregnancy)

  7. Risk factors of CB-PTSD : Fear of childbirth I (Mother)

    Fear of childbirth, 1 item

    Measured: Baseline (Third trimester of pregnancy)

  8. Risk factors of CB-PTSD : Fear of childbirth (Partner)

    Fear of childbirth, 1 item

    Measured: Baseline (Third trimester of pregnancy)

  9. Risk factors of CB-PTSD : Fear of childbirth II (Mother)

    Fear of Childbirth Questionnaire (FCQ; Slade et al., 2022), 20 items scored on a 4-point scale

    Measured: Baseline (Third trimester of pregnancy)

  10. Risk factors of CB-PTSD : Antenatal Stress (Mother)

    Antenatal Perceived Stress Inventory (APSI (Razurel et al., 2014), 12 items scored on a 5-point scale

    Measured: Baseline (Third trimester of pregnancy)

  11. Risk factors of CB-PTSD : Previous trauma (Mother)

    Previous birth trauma, 1 item

    Measured: Baseline (Third trimester of pregnancy)

  12. Risk factors of CB-PTSD : Previous trauma (Partner)

    Previous birth trauma, 1 item

    Measured: Baseline (Third trimester of pregnancy)

  13. Risk factors of CB-PTSD : Previous birth trauma (Mother)

    Previous birth trauma, 1 item

    Measured: Baseline (Third trimester of pregnancy)

  14. Risk factors of CB-PTSD : Previous birth trauma (Partner)

    Previous birth trauma, 1 item

    Measured: Baseline (Third trimester of pregnancy)

  15. Risk factors of CB-PTSD : Prenatal attachment (Mother)

    Prenatal Attachment Inventory (PAI; Jurgens et al., 2010), 21 items scored on a 4-point scale

    Measured: Baseline (Third trimester of pregnancy)

  16. Risk factors of CB-PTSD : Relationship satisfaction (Mother)

    Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale

    Measured: Baseline (Third trimester of pregnancy)

  17. Risk factors of CB-PTSD : Relationship satisfaction (Partner)

    Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale

    Measured: Baseline (Third trimester of pregnancy)

  18. Risk factors of CB-PTSD : Social Support (Mother)

    Modified Medical Outcomes Study Social Support Survey (mMOS-SS; Moser et al., 2012), 8 items scored on a 5-point scale

    Measured: Baseline (Third trimester of pregnancy)

  19. Risk factors of CB-PTSD : Social Support (Partner)

    Modified Medical Outcomes Study Social Support Survey (mMOS-SS; Moser et al., 2012), 8 items scored on a 5-point scale

    Measured: Baseline (Third trimester of pregnancy)

  20. Consequences of CB-PTSD : Anxiety (Mother)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  21. Consequences of CB-PTSD : Anxiety (Partner)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  22. Consequences of CB-PTSD : Depression (Mother)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  23. Consequences of CB-PTSD : Depression (Partner)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  24. Consequences of CB-PTSD : Mother-infant bonding I (Mother)

    Postpartum Bonding Questionnaire (PPBQ; Demanche et al., 2021), 25 items scored on a 5-point scale

    Measured: 6-12 weeks postpartum

  25. Consequences of CB-PTSD : Mother-infant bonding II (Mother)

    Parent-Infant Bonding Scale (MIBS; Bienfait et al., 2017), 8 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  26. Consequences of CB-PTSD : Father-infant bonding (Partner)

    Parent-Infant Bonding Scale (MIBS; Bienfait et al., 2017), 8 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  27. Consequences of CB-PTSD : Relationship satisfaction (Mother)

    Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale

    Measured: 6-12 weeks postpartum

  28. Consequences of CB-PTSD : Relationship satisfaction (Partner)

    Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale

    Measured: 6-12 weeks postpartum

  29. Consequences of CB-PTSD : Coparenting (Mother)

    Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale

    Measured: 6-12 weeks postpartum

  30. Consequences of CB-PTSD : Coparenting (Partner)

    Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale

    Measured: 6-12 weeks postpartum

  31. Consequences of CB-PTSD : Parenting self-efficacy (Mother)

    Perceived Maternal Parenting Self-Efficacy (PMP-SE; Schneider et al., 2019), 20 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  32. Consequences of CB-PTSD : Parenting self-efficacy (Partner)

    Perceived Maternal Parenting Self-Efficacy (PMP-SE; Schneider et al., 2019), 20 items scored on a 4-point scale

    Measured: 6-12 weeks postpartum

  33. Consequences of CB-PTSD : Healthcare renunciation (Mother)

    Healthcare renunciation, 3 items

    Measured: 6-12 weeks postpartum

  34. Consequences of CB-PTSD : Healthcare renunciation (Partner)

    Healthcare renunciation, 3 items

    Measured: 6-12 weeks postpartum

  35. Consequences of CB-PTSD : Anxiety (Mother)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: 6 months postpartum

  36. Consequences of CB-PTSD : Anxiety (Partner)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: 6 months postpartum

  37. Consequences of CB-PTSD : Depression (Mother)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: 6 months postpartum

  38. Consequences of CB-PTSD : Depression (Partner)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: 6 months postpartum

  39. Consequences of CB-PTSD : Mother-infant bonding (Mother)

    Postpartum Bonding Questionnaire (PPBQ; Demanche et al., 2021), 25 items scored on a 5-point scale

    Measured: 6 months postpartum

  40. Consequences of CB-PTSD : Support from neighborhood (Mother)

    Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale

    Measured: 6 months postpartum

  41. Consequences of CB-PTSD : Support from neighborhood (Partner)

    Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale

    Measured: 6 months postpartum

  42. Consequences of CB-PTSD : Anxiety (Mother)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: 12 months postpartum

  43. Consequences of CB-PTSD : Anxiety (Partner)

    Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale

    Measured: 12 months postpartum

  44. Consequences of CB-PTSD : Depression (Mother)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: 12 months postpartum

  45. Consequences of CB-PTSD : Depression (Partner)

    Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale

    Measured: 12 months postpartum

  46. Consequences of CB-PTSD : Relationship satisfaction (Mother)

    Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale

    Measured: 12 months postpartum

  47. Consequences of CB-PTSD : Relationship satisfaction (Partner)

    Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale

    Measured: 12 months postpartum

  48. Consequences of CB-PTSD : Coparenting (Mother)

    Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale

    Measured: 12 months postpartum

  49. Consequences of CB-PTSD : Coparenting (Partner)

    Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale

    Measured: 12 months postpartum

  50. Consequences of CB-PTSD : Support from neighborhood (Mother)

    Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale

    Measured: 12 months postpartum

  51. Consequences of CB-PTSD : Support from neighborhood (Partner)

    Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale

    Measured: 12 months postpartum

  52. Consequences of CB-PTSD : Healthcare renunciation (Mother)

    Healthcare renunciation, 3 items

    Measured: 12 months postpartum

  53. Consequences of CB-PTSD : Healthcare renunciation (Partner)

    Healthcare renunciation, 3 items

    Measured: 12 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 May 2023
  2. Study start1 May 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (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
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865704
Sponsor's protocol ID
2022-284
Acronym
SwiTCH
Status last verified
May 2023
First submitted
21 Mar 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The IPD will be available upon request

Publications

  • Chanvrier H, Rattaz V, Offredi V, Dupuis M, Horsch A. Swiss cohort on Traumatic Childbirth and Health (SwiTCH): protocol for a prospective, population-based cohort study on parents' mental health from pregnancy to one year postpartum. BMJ Open. 2024 Jan 30;14(1):e080557. doi: 10.1136/bmjopen-2023-080557.

    PubMed 38296274

Questions about this trial

What is this clinical trial studying?

An observational study of Post Traumatic Stress Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 1 inclusion and 1 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 May 2023. 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 Switzerland. 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 Antje Horsch, Prof. (+41213148571, antje.horsch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of childbirth trauma in mother and partner (time frame: 6-12 weeks postpartum). The study lists 4 primary outcomes in all. 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 NCT05865704, 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 May 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in