NCT05865704

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

March 21, 2023

Last Update Submit

May 9, 2023

Conditions

Post Traumatic Stress Disorder

Keywords

childbirthposttraumatic stress disorderbirth trauma

Outcome Measures

Primary Outcomes (4)

  • Prevalence of childbirth trauma in mother and partner

    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)

    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)

    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)

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

    12 months postpartum

Secondary Outcomes (53)

  • Risk factors of CB-PTSD : History of mental health issues (Mother)

    Baseline (Third trimester of pregnancy)

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

    Baseline (Third trimester of pregnancy)

  • Risk factors of CB-PTSD : Anxiety (Mother)

    Baseline (Third trimester of pregnancy)

  • Risk factors of CB-PTSD : Anxiety (Partner)

    Baseline (Third trimester of pregnancy)

  • Risk factors of CB-PTSD : Depression (Mother)

    Baseline (Third trimester of pregnancy)

  • +48 more secondary outcomes

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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...)

You may not qualify if:

  • N/A.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38296274DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticBirth Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Antje Horsch

    UNIL-CHUV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antje Horsch, Prof.

CONTACT

+41213148571antje.horsch@chuv.ch

Valentin Offredi

CONTACT

021 314 92 64valentin.offredi@chuv.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 21, 2023

First Posted

May 19, 2023

Study Start

May 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

CH(1)