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

Post Traumatic Stress Disorder Clinical Trial

— SwiTCH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865704
• Other study ID #: 2022-284
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Antje Horsch, Prof.
• Phone: +41213148571
• Email: antje.horsch[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of childbirth trauma in mother and partner	Measure of the extent to which the birth is perceived as traumatic	6-12 weeks postpartum
Primary	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).	6-12 weeks postpartum
Primary	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).	6 months postpartum
Primary	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).	12 months postpartum
Secondary	Risk factors of CB-PTSD : History of mental health issues (Mother)	History of mental health issues/treatment, 4 items	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : History of mental health issues (Partner)	History of mental health issues/treatment, 4 items	Baseline (Third trimester of pregnancy)
Secondary	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	Baseline (Third trimester of pregnancy)
Secondary	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	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Depression (Mother)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Depression (Patner)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Fear of childbirth I (Mother)	Fear of childbirth, 1 item	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Fear of childbirth (Partner)	Fear of childbirth, 1 item	Baseline (Third trimester of pregnancy)
Secondary	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	Baseline (Third trimester of pregnancy)
Secondary	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	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Previous trauma (Mother)	Previous birth trauma, 1 item	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Previous trauma (Partner)	Previous birth trauma, 1 item	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Previous birth trauma (Mother)	Previous birth trauma, 1 item	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Previous birth trauma (Partner)	Previous birth trauma, 1 item	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Prenatal attachment (Mother)	Prenatal Attachment Inventory (PAI; Jurgens et al., 2010), 21 items scored on a 4-point scale	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Relationship satisfaction (Mother)	Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale	Baseline (Third trimester of pregnancy)
Secondary	Risk factors of CB-PTSD : Relationship satisfaction (Partner)	Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale	Baseline (Third trimester of pregnancy)
Secondary	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	Baseline (Third trimester of pregnancy)
Secondary	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	Baseline (Third trimester of pregnancy)
Secondary	Consequences of CB-PTSD : Anxiety (Mother)	Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Anxiety (Partner)	Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Depression (Mother)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Depression (Partner)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	6-12 weeks postpartum
Secondary	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	6-12 weeks postpartum
Secondary	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	6-12 weeks postpartum
Secondary	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	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Relationship satisfaction (Mother)	Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Relationship satisfaction (Partner)	Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Coparenting (Mother)	Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Coparenting (Partner)	Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale	6-12 weeks postpartum
Secondary	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	6-12 weeks postpartum
Secondary	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	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Healthcare renunciation (Mother)	Healthcare renunciation, 3 items	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Healthcare renunciation (Partner)	Healthcare renunciation, 3 items	6-12 weeks postpartum
Secondary	Consequences of CB-PTSD : Anxiety (Mother)	Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale	6 months postpartum
Secondary	Consequences of CB-PTSD : Anxiety (Partner)	Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale	6 months postpartum
Secondary	Consequences of CB-PTSD : Depression (Mother)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	6 months postpartum
Secondary	Consequences of CB-PTSD : Depression (Partner)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	6 months postpartum
Secondary	Consequences of CB-PTSD : Mother-infant bonding (Mother)	Postpartum Bonding Questionnaire (PPBQ; Demanche et al., 2021), 25 items scored on a 5-point scale	6 months postpartum
Secondary	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	6 months postpartum
Secondary	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	6 months postpartum
Secondary	Consequences of CB-PTSD : Anxiety (Mother)	Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Anxiety (Partner)	Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Depression (Mother)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Depression (Partner)	Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Relationship satisfaction (Mother)	Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Relationship satisfaction (Partner)	Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Coparenting (Mother)	Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale	12 months postpartum
Secondary	Consequences of CB-PTSD : Coparenting (Partner)	Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale	12 months postpartum
Secondary	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	12 months postpartum
Secondary	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	12 months postpartum
Secondary	Consequences of CB-PTSD : Healthcare renunciation (Mother)	Healthcare renunciation, 3 items	12 months postpartum
Secondary	Consequences of CB-PTSD : Healthcare renunciation (Partner)	Healthcare renunciation, 3 items	12 months postpartum