Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
Study NCT ID:
NCT05865704
Status:
RECRUITING
Last Update Posted:
2023-05-19
First Post:
2023-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Childbirth-related Post-traumatic Stress Disorder in Switzerland: The Swiss Cohort on Traumatic Childbirth and Health
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SwiTCH
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
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
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: