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

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Recruiting
CT.gov ID
NCT05865704
Collaborator
(none)
1,000
1
43
23.2

Study Details

Study Description

Brief 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 factors or further consequences.

The main questions it aims to answer are :
  • 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

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of childbirth trauma in mother and partner [6-12 weeks postpartum]

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

    2. Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS) [6-12 weeks postpartum]

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

    3. Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS) [6 months postpartum]

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

    4. Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS) [12 months postpartum]

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

    Secondary Outcome Measures

    1. Risk factors of CB-PTSD : History of mental health issues (Mother) [Baseline (Third trimester of pregnancy)]

      History of mental health issues/treatment, 4 items

    2. Risk factors of CB-PTSD : History of mental health issues (Partner) [Baseline (Third trimester of pregnancy)]

      History of mental health issues/treatment, 4 items

    3. Risk factors of CB-PTSD : Anxiety (Mother) [Baseline (Third trimester of pregnancy)]

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

    4. Risk factors of CB-PTSD : Anxiety (Partner) [Baseline (Third trimester of pregnancy)]

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

    5. Risk factors of CB-PTSD : Depression (Mother) [Baseline (Third trimester of pregnancy)]

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

    6. Risk factors of CB-PTSD : Depression (Patner) [Baseline (Third trimester of pregnancy)]

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

    7. Risk factors of CB-PTSD : Fear of childbirth I (Mother) [Baseline (Third trimester of pregnancy)]

      Fear of childbirth, 1 item

    8. Risk factors of CB-PTSD : Fear of childbirth (Partner) [Baseline (Third trimester of pregnancy)]

      Fear of childbirth, 1 item

    9. Risk factors of CB-PTSD : Fear of childbirth II (Mother) [Baseline (Third trimester of pregnancy)]

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

    10. Risk factors of CB-PTSD : Antenatal Stress (Mother) [Baseline (Third trimester of pregnancy)]

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

    11. Risk factors of CB-PTSD : Previous trauma (Mother) [Baseline (Third trimester of pregnancy)]

      Previous birth trauma, 1 item

    12. Risk factors of CB-PTSD : Previous trauma (Partner) [Baseline (Third trimester of pregnancy)]

      Previous birth trauma, 1 item

    13. Risk factors of CB-PTSD : Previous birth trauma (Mother) [Baseline (Third trimester of pregnancy)]

      Previous birth trauma, 1 item

    14. Risk factors of CB-PTSD : Previous birth trauma (Partner) [Baseline (Third trimester of pregnancy)]

      Previous birth trauma, 1 item

    15. Risk factors of CB-PTSD : Prenatal attachment (Mother) [Baseline (Third trimester of pregnancy)]

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

    16. Risk factors of CB-PTSD : Relationship satisfaction (Mother) [Baseline (Third trimester of pregnancy)]

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

    17. Risk factors of CB-PTSD : Relationship satisfaction (Partner) [Baseline (Third trimester of pregnancy)]

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

    18. Risk factors of CB-PTSD : Social Support (Mother) [Baseline (Third trimester of pregnancy)]

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

    19. Risk factors of CB-PTSD : Social Support (Partner) [Baseline (Third trimester of pregnancy)]

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

    20. Consequences of CB-PTSD : Anxiety (Mother) [6-12 weeks postpartum]

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

    21. Consequences of CB-PTSD : Anxiety (Partner) [6-12 weeks postpartum]

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

    22. Consequences of CB-PTSD : Depression (Mother) [6-12 weeks postpartum]

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

    23. Consequences of CB-PTSD : Depression (Partner) [6-12 weeks postpartum]

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

    24. Consequences of CB-PTSD : Mother-infant bonding I (Mother) [6-12 weeks postpartum]

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

    25. Consequences of CB-PTSD : Mother-infant bonding II (Mother) [6-12 weeks postpartum]

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

    26. Consequences of CB-PTSD : Father-infant bonding (Partner) [6-12 weeks postpartum]

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

    27. Consequences of CB-PTSD : Relationship satisfaction (Mother) [6-12 weeks postpartum]

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

    28. Consequences of CB-PTSD : Relationship satisfaction (Partner) [6-12 weeks postpartum]

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

    29. Consequences of CB-PTSD : Coparenting (Mother) [6-12 weeks postpartum]

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

    30. Consequences of CB-PTSD : Coparenting (Partner) [6-12 weeks postpartum]

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

    31. Consequences of CB-PTSD : Parenting self-efficacy (Mother) [6-12 weeks postpartum]

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

    32. Consequences of CB-PTSD : Parenting self-efficacy (Partner) [6-12 weeks postpartum]

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

    33. Consequences of CB-PTSD : Healthcare renunciation (Mother) [6-12 weeks postpartum]

      Healthcare renunciation, 3 items

    34. Consequences of CB-PTSD : Healthcare renunciation (Partner) [6-12 weeks postpartum]

      Healthcare renunciation, 3 items

    35. Consequences of CB-PTSD : Anxiety (Mother) [6 months postpartum]

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

    36. Consequences of CB-PTSD : Anxiety (Partner) [6 months postpartum]

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

    37. Consequences of CB-PTSD : Depression (Mother) [6 months postpartum]

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

    38. Consequences of CB-PTSD : Depression (Partner) [6 months postpartum]

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

    39. Consequences of CB-PTSD : Mother-infant bonding (Mother) [6 months postpartum]

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

    40. Consequences of CB-PTSD : Support from neighborhood (Mother) [6 months postpartum]

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

    41. Consequences of CB-PTSD : Support from neighborhood (Partner) [6 months postpartum]

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

    42. Consequences of CB-PTSD : Anxiety (Mother) [12 months postpartum]

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

    43. Consequences of CB-PTSD : Anxiety (Partner) [12 months postpartum]

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

    44. Consequences of CB-PTSD : Depression (Mother) [12 months postpartum]

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

    45. Consequences of CB-PTSD : Depression (Partner) [12 months postpartum]

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

    46. Consequences of CB-PTSD : Relationship satisfaction (Mother) [12 months postpartum]

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

    47. Consequences of CB-PTSD : Relationship satisfaction (Partner) [12 months postpartum]

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

    48. Consequences of CB-PTSD : Coparenting (Mother) [12 months postpartum]

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

    49. Consequences of CB-PTSD : Coparenting (Partner) [12 months postpartum]

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

    50. Consequences of CB-PTSD : Support from neighborhood (Mother) [12 months postpartum]

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

    51. Consequences of CB-PTSD : Support from neighborhood (Partner) [12 months postpartum]

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

    52. Consequences of CB-PTSD : Healthcare renunciation (Mother) [12 months postpartum]

      Healthcare renunciation, 3 items

    53. Consequences of CB-PTSD : Healthcare renunciation (Partner) [12 months postpartum]

      Healthcare renunciation, 3 items

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • N/A.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lausanne University Hospital Lausanne Vaud Switzerland 1011

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Vaudois

    Investigators

    • Principal Investigator: Antje Horsch, UNIL-CHUV

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antje Horsch, Prof., Centre Hospitalier Universitaire Vaudois
    ClinicalTrials.gov Identifier:
    NCT05865704
    Other Study ID Numbers:
    • 2022-284
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Antje Horsch, Prof., Centre Hospitalier Universitaire Vaudois
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2023