- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865704
Childbirth-related Post-traumatic Stress Disorder in Switzerland: The Swiss Cohort on Traumatic Childbirth and Health (SwiTCH)
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 :
- 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
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Antje Horsch, Prof.
- Phone Number: +41213148571
- Email: antje.horsch@chuv.ch
Study Contact Backup
- Name: Valentin Offredi
- Phone Number: 021 314 92 64
- Email: valentin.offredi@chuv.ch
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- Recruiting
- Lausanne University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of childbirth trauma in mother and partner
Time Frame: 6-12 weeks postpartum
|
Measure of the extent to which the birth is perceived as traumatic
|
6-12 weeks postpartum
|
|
Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS)
Time Frame: 6-12 weeks postpartum
|
Childbirth-related PTSD and PTSS is assessed with the City Birth Trauma Scale (City BiTS).
|
6-12 weeks postpartum
|
|
Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS)
Time Frame: 6 months postpartum
|
Childbirth-related PTSD and PTSS is assessed with the City Birth Trauma Scale (City BiTS).
|
6 months postpartum
|
|
Prevalence of childbirth Posttraumatic Stress Disorder (PTSD) and childbirth Postraumatic Stress Symptoms (PTSS)
Time Frame: 12 months postpartum
|
Childbirth-related PTSD and PTSS is assessed with the City Birth Trauma Scale (City BiTS).
|
12 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors of CB-PTSD : History of mental health issues (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
History of mental health issues/treatment, 4 items
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : History of mental health issues (Partner)
Time Frame: Baseline (Third trimester of pregnancy)
|
History of mental health issues/treatment, 4 items
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Anxiety (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Anxiety (Partner)
Time Frame: Baseline (Third trimester of pregnancy)
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Depression (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Depression (Patner)
Time Frame: Baseline (Third trimester of pregnancy)
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Fear of childbirth I (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Fear of childbirth, 1 item
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Fear of childbirth (Partner)
Time Frame: Baseline (Third trimester of pregnancy)
|
Fear of childbirth, 1 item
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Fear of childbirth II (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Fear of Childbirth Questionnaire (FCQ; Slade et al., 2022), 20 items scored on a 4-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Antenatal Stress (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Antenatal Perceived Stress Inventory (APSI (Razurel et al., 2014), 12 items scored on a 5-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Previous trauma (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Previous birth trauma, 1 item
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Previous trauma (Partner)
Time Frame: Baseline (Third trimester of pregnancy)
|
Previous birth trauma, 1 item
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Previous birth trauma (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Previous birth trauma, 1 item
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Previous birth trauma (Partner)
Time Frame: Baseline (Third trimester of pregnancy)
|
Previous birth trauma, 1 item
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Prenatal attachment (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Prenatal Attachment Inventory (PAI; Jurgens et al., 2010), 21 items scored on a 4-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Relationship satisfaction (Mother)
Time Frame: Baseline (Third trimester of pregnancy)
|
Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Relationship satisfaction (Partner)
Time Frame: Baseline (Third trimester of pregnancy)
|
Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Social Support (Mother)
Time Frame: 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
|
Baseline (Third trimester of pregnancy)
|
|
Risk factors of CB-PTSD : Social Support (Partner)
Time Frame: 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
|
Baseline (Third trimester of pregnancy)
|
|
Consequences of CB-PTSD : Anxiety (Mother)
Time Frame: 6-12 weeks postpartum
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Anxiety (Partner)
Time Frame: 6-12 weeks postpartum
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Depression (Mother)
Time Frame: 6-12 weeks postpartum
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Depression (Partner)
Time Frame: 6-12 weeks postpartum
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Mother-infant bonding I (Mother)
Time Frame: 6-12 weeks postpartum
|
Postpartum Bonding Questionnaire (PPBQ; Demanche et al., 2021), 25 items scored on a 5-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Mother-infant bonding II (Mother)
Time Frame: 6-12 weeks postpartum
|
Parent-Infant Bonding Scale (MIBS; Bienfait et al., 2017), 8 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Father-infant bonding (Partner)
Time Frame: 6-12 weeks postpartum
|
Parent-Infant Bonding Scale (MIBS; Bienfait et al., 2017), 8 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Relationship satisfaction (Mother)
Time Frame: 6-12 weeks postpartum
|
Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Relationship satisfaction (Partner)
Time Frame: 6-12 weeks postpartum
|
Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Coparenting (Mother)
Time Frame: 6-12 weeks postpartum
|
Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Coparenting (Partner)
Time Frame: 6-12 weeks postpartum
|
Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Parenting self-efficacy (Mother)
Time Frame: 6-12 weeks postpartum
|
Perceived Maternal Parenting Self-Efficacy (PMP-SE; Schneider et al., 2019), 20 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Parenting self-efficacy (Partner)
Time Frame: 6-12 weeks postpartum
|
Perceived Maternal Parenting Self-Efficacy (PMP-SE; Schneider et al., 2019), 20 items scored on a 4-point scale
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Healthcare renunciation (Mother)
Time Frame: 6-12 weeks postpartum
|
Healthcare renunciation, 3 items
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Healthcare renunciation (Partner)
Time Frame: 6-12 weeks postpartum
|
Healthcare renunciation, 3 items
|
6-12 weeks postpartum
|
|
Consequences of CB-PTSD : Anxiety (Mother)
Time Frame: 6 months postpartum
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Anxiety (Partner)
Time Frame: 6 months postpartum
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Depression (Mother)
Time Frame: 6 months postpartum
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Depression (Partner)
Time Frame: 6 months postpartum
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Mother-infant bonding (Mother)
Time Frame: 6 months postpartum
|
Postpartum Bonding Questionnaire (PPBQ; Demanche et al., 2021), 25 items scored on a 5-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Support from neighborhood (Mother)
Time Frame: 6 months postpartum
|
Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Support from neighborhood (Partner)
Time Frame: 6 months postpartum
|
Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale
|
6 months postpartum
|
|
Consequences of CB-PTSD : Anxiety (Mother)
Time Frame: 12 months postpartum
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Anxiety (Partner)
Time Frame: 12 months postpartum
|
Hospital Anxiety and Depression Scale (HADS; Untas et al., 2009), 7 items scored on a 4-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Depression (Mother)
Time Frame: 12 months postpartum
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Depression (Partner)
Time Frame: 12 months postpartum
|
Edinburgh Postnatal Depression Scale (EPDS; Guedeney et al., 1998), 10 items scored on a 4-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Relationship satisfaction (Mother)
Time Frame: 12 months postpartum
|
Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Relationship satisfaction (Partner)
Time Frame: 12 months postpartum
|
Relationship assessment scale (RAS; Saramago et al., 2021), 7 items scored on a 5-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Coparenting (Mother)
Time Frame: 12 months postpartum
|
Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Coparenting (Partner)
Time Frame: 12 months postpartum
|
Coparenting Relationship Scale (CRS; Favez et al., 2021), 35 items scored on a 7-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Support from neighborhood (Mother)
Time Frame: 12 months postpartum
|
Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Support from neighborhood (Partner)
Time Frame: 12 months postpartum
|
Perceived Neighborhood Social Cohesion (P-NSC; Dupuis et al., 2017), 9 items scored on a 7-point scale
|
12 months postpartum
|
|
Consequences of CB-PTSD : Healthcare renunciation (Mother)
Time Frame: 12 months postpartum
|
Healthcare renunciation, 3 items
|
12 months postpartum
|
|
Consequences of CB-PTSD : Healthcare renunciation (Partner)
Time Frame: 12 months postpartum
|
Healthcare renunciation, 3 items
|
12 months postpartum
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antje Horsch, UNIL-CHUV
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-284
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Traumatic Stress Disorder
-
Acacia ClinicsElectroCore INC; Vagus Nerve SocietyRecruitingPTSD | Post Traumatic Stress Disorder | Post Traumatic Stress Disorders | Post-traumatic Stress Disorder (PTSD) | Post Traumatic Stress Disorder PTSD | PTSD - Post Traumatic Stress Disorder | Post-Traumatic Stress Disorder, PTSDUnited States
-
University of LuxembourgQuresta, Inc.; National Psychological Association of Ukraine; Veteran Mental...RecruitingPost Traumatic Stress Disorder | Post Traumatic Stress Disorder PTSD | Post-Traumatic Stress Disorder, PTSDUkraine
-
Istanbul UniversityRecruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD)Turkey
-
Istanbul UniversityRecruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD)Turkey
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
University of California, Los AngelesWithdrawnPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
IWK Health CentreRecruitingPost-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder, PTSD | Post-Traumatic Stress Disorder in YouthCanada
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of ZurichCompletedPost Traumatic Stress Disorder (PTSD) | Complex Post-Traumatic Stress Disorder (CPTSD)Switzerland