Parental Well-being After Childbirth in Switzerland

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorLaurent Gaucher

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Refusal to participate

Inability to provide informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
2 months postpartum

Secondary outcomes

1

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.

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

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'.

Time frame
At birth, and at 2, 6, and 12 months postpartum
3

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.

Time frame
At birth (Obstetric Quality of Recovery-10), and at 2, 6, and 12 months postpartum (pain and incontinence)
4

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.

Time frame
6 and 12 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laurent Gaucher

Lead sponsor

School of Health Sciences Geneva

Sponsor institution