NCT06886841

Brief Summary

Improving maternal and child health is a global priority, with increasing emphasis on ensuring women and their families not only survive but also thrive after childbirth. While high-income countries like Switzerland provide strong antenatal and intrapartum care, the quality of postnatal care often lags behind, despite the critical physical, mental, and social needs of the postpartum period. Studies indicate high rates of mental distress, physical pain, and sexual discomfort among mothers, alongside a lack of research on the well-being of co-parents. The main question this cohort study aims to answer is: how do the health and well-being of mothers and co-parents evolve during the first year after childbirth? Participants will complete four online questionnaires: the first within the first few days after birth, followed by additional assessments at 2, 6, and 12 months postpartum. This comprehensive approach seeks to inform policy and improve evidence-based postnatal care practices, benefiting approximately 80,000 families annually in Switzerland.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

March 12, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 12, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

childbirth-related post-traumatic stress disordermental healthpostpartumparental wellbeingphysical healthsexual healthsocial supportquality of lifequality of carepostpartum depressionmotherscoparents

Outcome Measures

Primary Outcomes (1)

  • Childbirth-related post-traumatic stress disorder

    The prevalence of childbirth-related post-traumatic stress disorder in both parents will be assessed using the validated City Birth Trauma Scale (City BiTS). This self-reported questionnaire consists of 29 items, 20 of which measure the frequency of trauma symptoms, including intrusive thoughts, avoidance, negative mood, and hyperarousal, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Items are rated using a four-point Likert-type scale, ranging from 0 to 3. The total score varies from 0 to 60 points, with higher scores indicating a higher level of PTSD-symptoms.

    2 months postpartum

Secondary Outcomes (5)

  • Postpartum depression and anxiety

    At birth, and at 2, 6, and 12 months postpartum

  • Health-related quality of life

    At birth, and at 2, 6, and 12 months postpartum

  • Physical recovery

    At birth (Obstetric Quality of Recovery-10), and at 2, 6, and 12 months postpartum (pain and incontinence)

  • Sexual health

    6 and 12 months postpartum

  • Hospitalisations

    From one year before to one year after childbirth

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult women who give birth to one or more live-born or stillborn children at ≥22 weeks and/or with a birthweight of ≥500 grams in a participating unit during the study period will be eligible, along with their cohabiting partners.

You may qualify if:

  • Women who give birth in a participating maternity unit or birth center during the study period.
  • Partner of a participating women: the partner must be designated by the mother, live with her at the time of birth, and only one partner can be included per mother.
  • Gestational age at birth: ≥22+0 weeks and/or birthweight ≥500 grams
  • Age: Participants must be 14 years or older.
  • Language Proficiency: Participants must have sufficient proficiency in one of Switzerland's main official languages (German, French, Italian) or English to ensure accurate communication and comprehension of study materials.

You may not qualify if:

  • Refusal to participate
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haute Ecole de Santé Genève

Geneva, 1206, Switzerland

RECRUITING

ZHAW Zurich University of Applied Sciences

Winterthur, Switzerland

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingStress Disorders, Post-TraumaticDepression, Postpartum

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Study Officials

  • Laurent Gaucher, RM, PhD

    Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 20, 2025

Study Start

March 17, 2025

Primary Completion

August 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

In compliance with the requirements of the Swiss National Science Foundation, anonymized study data will be made available to other researchers via Yareta, a certified and secure Swiss institutional research data repository. This ensures transparency, facilitates further research, and aligns with FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. Access to the data on this platform is subject to authorization by a competent authority.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Undecided
Access Criteria
Researchers will have access to the IPD and supporting information. Data access via the YARETA platform is subject to authorization by a competent authority.
More information

Locations