Mental HealthSOCRATESNCT06886841
Parental Well-being After Childbirth in Switzerland
An observational study of Mental Health and Physical Health, run by Laurent Gaucher at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Mental Health, Physical Health, Postpartum
- How many people
- 4,200 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 17 Mar 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Haute Ecole de Santé Genève
Geneva, 1206
Laurent Gaucher, RM, PhD, +41 22 558 68 96, laurent.gaucher@hesge.ch
Elsa Lorthe, RM, PhD, elsa.lorthe@hesge.ch
- Recruiting
ZHAW Zurich University of Applied Sciences
Winterthur
Susanne Grylka, RM, PhD, +41 58 934 43 77, susanne.grylka@zhaw.ch
Susanne Grylka, RM, PhD
About this study
Official title: Stress Of Co-parents Related to A Traumatic Experience of Birth Across Switzerland
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.
- Conditions
- Mental Health, Physical Health, Postpartum, Parents, Quality of Life, Quality of Care
- Keywords
- childbirth-related post-traumatic stress disorder, mental health, postpartum, parental wellbeing, physical health, sexual health, social support, quality of life, quality of care, postpartum depression, mothers, coparents
- Medical subject headings
- Psychological Well-Being, Stress Disorders, Post-Traumatic, Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months postpartum
Secondary outcomes (5)
Postpartum depression and anxiety
Postpartum depression and anxiety will be assessed in both parents, using the Edinburgh Postnatal Depression Scale (EPDS) at birth, and at 2, 6, and 12 months postpartum. This validated 10-item questionnaire screens for symptoms of depression and anxiety. Responses are rated on a four-point Likert scale, ranging from 0 to 3. The total score ranges from 0 to 30 points, with higher scores indicating a greater risk of depression.
Measured: At birth, and at 2, 6, and 12 months postpartum
Health-related quality of life
Assessed in both parents with the EuroQoL 5-Dimension 5-Level scale (EQ-5D-5L), along with a visual analogue scale for self-rated health (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a visual analogue scale ranging from 0 to 100 where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: At birth, and at 2, 6, and 12 months postpartum
Physical recovery
Mothers' quality of recovery after childbirth, will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) tool. This validated, self-reported measure evaluates pain, physical symptoms, mobility, self-care, and baby care on an 11-point scale ranging from 0 (worst outcome) to 10 (best outcome). The total score ranges from 0 to 100, with higher scores indicating better recovery quality. Additional dimensions, in particular pain and incontinence, will also be evaluated in mothers.
Measured: At birth (Obstetric Quality of Recovery-10), and at 2, 6, and 12 months postpartum (pain and incontinence)
Sexual health
Assessed at 6 and 12 months postpartum in mothers using the Female Sexual Function Index (FSFI-6), a validated questionnaire that can be used to screen for sexual dysfunction in women. It consists of 6 items covering 6 domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Each item of the FSFI-6 questionnaire is associated with a 5-point ordinal scale, in which 5 represents optimal function and 1 the poorest function. The scores for each domain are summed to provide a total score, with a higher score indicating better sexual function.
Measured: 6 and 12 months postpartum
Hospitalisations
Collected through linkage with the "Medical Statistics of Hospitals" database, this outcome includes the frequency, reasons, and costs of hospitalisations from one year before to one year after childbirth. This data provides critical insights into severe health outcomes and rehospitalisations in mothers and infants.
Measured: From one year before to one year after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start17 Mar 2025
- Primary completionAug 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laurent Gaucher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laurent Gaucher, School of Health Sciences Geneva
- Investigators
- Laurent Gaucher, RM, PhD, Principal investigator, Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886841
- Sponsor's protocol ID
- G700026130408
- Other IDs
- 220494
- Acronym
- SOCRATES
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Gaucher L, Desplanches T, Sormani J, Cattani G, Mueller AN, Celetta E, Widmer IN, Lorthe E, Grylka-Baeschlin S. Health and well-being of mothers and co-parents during the first 12 months post partum: study protocol of the national SOCRATES cohort study in Switzerland. BMJ Open. 2026 Jun 4;16(6):e121443. doi: 10.1136/bmjopen-2026-121443.
PubMed 42242736
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Of Co-parents Related to A Traumatic Experience of Birth Across Switzerland
- ClinicalTrials.gov ID
- NCT06886841
- Acronym / sponsor ID
- SOCRATES / G700026130408
- Conditions
- Mental Health, Physical Health, Postpartum, Parents, Quality of Life, Quality of Care
- Keywords
- childbirth-related post-traumatic stress disorder, mental health, postpartum, parental wellbeing, physical health, sexual health, social support, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Laurent GaucherUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to participate
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Childbirth-related post-traumatic stress disorder
Time frame: 2 months postpartum
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.
5 secondary outcomes
Postpartum depression and anxiety
Time frame: At birth, and at 2, 6, and 12 months postpartum
Health-related quality of life
Time frame: At birth, and at 2, 6, and 12 months postpartum
Physical recovery
Time frame: At birth (Obstetric Quality of Recovery-10), and at 2, 6, and 12 months postpartum (pain and incontinence)
Sexual health
Time frame: 6 and 12 months postpartum
Hospitalisations
Time frame: From one year before to one year after childbirth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 42242736Gaucher L, Desplanches T, Sormani J, Cattani G, Mueller AN, Celetta E, Widmer IN, Lorthe E, Grylka-Baeschlin S. Health and well-being of mothers and co-parents during the first 12 months post partum: study protocol of the national SOCRATES cohort study in Switzerland. BMJ Open. 2026 Jun 4;16(6):e121443. doi: 10.1136/bmjopen-2026-121443.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Gaucher, RM, PhD principal investigator
Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Physical Health, run by Laurent Gaucher at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent GAUCHER, PhD (+41 22 558 68 96, laurent.gaucher@hesge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth-related post-traumatic stress disorder (time frame: 2 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.