Post Partum WomenVISIMATNCT07653646
Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the Auvergne Rhone-Alpes Region (AuRA)
A study testing psychological assessment in people with Post Partum Women and Newborn Health, run by Centre Hospitalier Annecy Genevois at 2 sites in France.
Trial summary
Maternal mental health in the postpartum period is a major public health issue in France. The 2021 National Perinatal Survey highlights high prevalence rates of mental health disorders among mothers, with 27.6% experiencing anxiety disorders, 16.7% experiencing depressive disorders and 5.4% having suicidal thoughts. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Women, Newborn Health
- What is being tested?
- psychological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jun 2026to Jun 2028
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patient (aged 18 or over),
- Female patient admitted to the maternity ward with her newborn baby or babies,
- Length of stay in the maternity ward of 48 hours or more,
- Female patient who has been informed about the study and has given her free, informed verbal consent to participate in the study.
Who cannot join
- Patients who have already participated in this study,
- Patients whose newborn(s) are hospitalised in neonatal units, neonatal intensive care units or neonatal resuscitation units,
- Patients who have given birth to three or more newborns (triplets or more),
- Patient whose newborn(s) has/have died,
- Patient unable to understand spoken or written French, making self-assessment impossible,
- Patient under guardianship, curatorship or placed under judicial protection,
- Patient not covered by the French social security system.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Annecy Genevois
Annecy, 74370
Noellie FANTINATO
- Not yet recruiting
CH Annecy Genevois
Épagny, Auvergne-Rhône-Alpes, 74370
Marion Beucher, PhD, +33450637032 ext. +33, mbeucher@ch-annecygenevois.fr
About this study
Official title: Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the AuRA Region
Maternal mental health in the postpartum period is a major public health issue in France. The 2021 National Perinatal Survey highlights high prevalence rates of mental health disorders among mothers, with 27.6% experiencing anxiety disorders, 16.7% experiencing depressive disorders and 5.4% having suicidal thoughts. Between 2016 and 2018, suicide was also the leading cause of maternal mortality in the year following childbirth, underscoring the severity and frequency of these disorders. In response, international guidelines, notably those of the World health Organisation (WHO), as well as national policies such as the 'First 1,000 Days' strategy, emphasise the importance of early, enhanced and individualised postnatal support. In France, this postpartum care tends to be structured around the Early Postnatal Interview and the recommended use of validated screening tools such as the Edinburgh Postnatal Depression Scale (EPDS).
However, the quality of postpartum care depends not only on screening and clinical follow-up, but also on organisational and environmental factors. Among these, the arrangements for maternity ward visits constitute a potential determinant of patients' experiences, likely to influence both their mental state, their rest, the establishment of breastfeeding and, indirectly, the health of the newborn. The exceptional measures implemented during the Covid-19 pandemic, notably the restriction of visits, have shown generally favourable effects, with improved satisfaction among patients and healthcare staff, better conditions for rest, facilitation of breastfeeding and a perceived improvement in working conditions.
Read more
However, these data were collected in an exceptional health context, which may introduce biases linked to the social, emotional and organisational constraints specific to this period. Their extrapolation to routine practice therefore remains uncertain. Furthermore, in the absence of specific national guidelines governing maternity ward visits, the current regulatory framework remains unclear and practices vary between institutions, often relying on local decisions that have not been scientifically evaluated.
Against this backdrop, the VISIMAT study aims to characterise maternity ward visiting arrangements outside of any exceptional circumstances and to assess their impact on the health of mothers and newborns, as well as on healthcare workers' working conditions. Its aim is to provide a scientific basis to inform the development of standardised recommendations and prevention messages.
- Conditions
- Post Partum Women, Newborn Health
- Being tested
- psychological assessment
- Keywords
- maternity wards visiting, mother health, newborn health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological assessmentOther
The only intervention resulting from the research consists of referring patients with an EPDS score ≥ 10 and/or a positive response to item 10 of this scale ('has already thought about harming themselves') to a psychologist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (additionnal psychological assessment) | Other | The only intervention prompted by the research involves referring patients with an EPDS score of ≥10 and/or a positive response to item 10 of the scale ('has already thought about harming themselves') to a psychologist. Receives: Other: psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of visitor restriction levels implemented in maternity wards on mothers' postnatal depressive symptoms
The incidence of depressive symptoms in the mother using the Edinburgh Postnatal Depression Scale (EPDS)
Measured: At discharge from hospitalization in the maternity ward, on average 48 hours
Effect of visitor restriction levels implemented in maternity wards on early indicators of newborn health.
Neonatal weight change between birth and discharge from the maternity ward, reflecting the newborn's early health status.
Measured: Until discharge from hospitalization in the maternity ward, on average 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start19 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum WomenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The VISIMAT prospective multicentre cohort study will be implemented in several maternity units across the Auvergne-Rhône-Alpes (AuRA) region. This is a non-randomised, low-risk, low-burden interventional study that compares the postpartum health status of mothers and newborns according to the level of restrictions on visits applied in their maternity unit. The only intervention resulting from the research consists of referring patients with an EPDS score ≥ 10 and/or a positive response to item 10 of this scale ('has already thought about harming themselves') to a psychologist.
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes
- Responsible party
- Sponsor
- Investigators
- Noëllie FANTINATO, Midwife, Principal investigator, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653646
- Sponsor's protocol ID
- 24-08
- Acronym
- VISIMAT
- Status last verified
- Oct 2026
- First submitted
- 28 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the AuRA Region
- ClinicalTrials.gov ID
- NCT07653646
- Acronym / sponsor ID
- VISIMAT / 24-08
- Conditions
- Post Partum Women, Newborn Health
- Keywords
- maternity wards visiting, mother health, newborn health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
Maternal mental health in the postpartum period is a major public health issue in France. The 2021 National Perinatal Survey highlights high prevalence rates of mental health disorders among mothers, with 27.6% experiencing anxiety disorders, 16.7% experiencing depressive disorders and 5.4% having suicidal thoughts. Between 2016 and 2018, suicide was also the leading cause of maternal mortality in the year following childbirth, underscoring the severity and frequency of these disorders. In response, international guidelines, notably those of the World health Organisation (WHO), as well as national policies such as the 'First 1,000 Days' strategy, emphasise the importance of early, enhanced and individualised postnatal support. In France, this postpartum care tends to be structured around the Early Postnatal Interview and the recommended use of validated screening tools such as the Edinburgh Postnatal Depression Scale (EPDS).
However, the quality of postpartum care depends not only on screening and clinical follow-up, but also on organisational and environmental factors. Among these, the arrangements for maternity ward visits constitute a potential determinant of patients' experiences, likely to influence both their mental state, their rest, the establishment of breastfeeding and, indirectly, the health of the newborn. The exceptional measures implemented during the Covid-19 pandemic, notably the restriction of visits, have shown generally favourable effects, with improved satisfaction among patients and healthcare staff, better conditions for rest, facilitation of breastfeeding and a perceived improvement in working conditions.
However, these data were collected in an exceptional health context, which may introduce biases linked to the social, emotional and organisational constraints specific to this period. Their extrapolation to routine practice therefore remains uncertain. Furthermore, in the absence of specific national guidelines governing maternity ward visits, the current regulatory framework remains unclear and practices vary between institutions, often relying on local decisions that have not been scientifically evaluated.
Against this backdrop, the VISIMAT study aims to characterise maternity ward visiting arrangements outside of any exceptional circumstances and to assess their impact on the health of mothers and newborns, as well as on healthcare workers' working conditions. Its aim is to provide a scientific basis to inform the development of standardised recommendations and prevention messages.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The VISIMAT prospective multicentre cohort study will be implemented in several maternity units across the Auvergne-Rhône-Alpes (AuRA) region. This is a non-randomised, low-risk, low-burden interventional study that compares the postpartum health status of mothers and newborns according to the level of restrictions on visits applied in their maternity unit. The only intervention resulting from the research consists of referring patients with an EPDS score ≥ 10 and/or a positive response to item 10 of this scale ('has already thought about harming themselves') to a psychologist.
| Arm | Type | Receives |
|---|---|---|
| Intervention (additionnal psychological assessment) | Other | Other: psychological assessmentThe only intervention prompted by the research involves referring patients with an EPDS score of ≥10 and/or a positive response to item 10 of the scale ('has already thought about harming themselves') to a psychologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult female patient (aged 18 or over),
- Female patient admitted to the maternity ward with her newborn baby or babies,
- Length of stay in the maternity ward of 48 hours or more,
- Female patient who has been informed about the study and has given her free, informed verbal consent to participate in the study.
Key exclusion criteria (7 listed)
- Patients who have already participated in this study,
- Patients whose newborn(s) are hospitalised in neonatal units, neonatal intensive care units or neonatal resuscitation units,
- Patients who have given birth to three or more newborns (triplets or more),
- Patient whose newborn(s) has/have died,
- Patient unable to understand spoken or written French, making self-assessment impossible,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological assessmentThe only intervention resulting from the research consists of referring patients with an EPDS score ≥ 10 and/or a positive response to item 10 of this scale ('has already thought about harming themselves') to a psychologist. | Other | Intervention (additionnal psychological assessment) |
Primary outcome
Effect of visitor restriction levels implemented in maternity wards on mothers' postnatal depressive symptoms
Time frame: At discharge from hospitalization in the maternity ward, on average 48 hours
The incidence of depressive symptoms in the mother using the Edinburgh Postnatal Depression Scale (EPDS)
Effect of visitor restriction levels implemented in maternity wards on early indicators of newborn health.
Time frame: Until discharge from hospitalization in the maternity ward, on average 48 hours.
Neonatal weight change between birth and discharge from the maternity ward, reflecting the newborn's early health status.
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 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Noëllie FANTINATO, Midwife principal investigator
Centre Hospitalier Annecy Genevois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological assessment in people with Post Partum Women and Newborn Health, run by Centre Hospitalier Annecy Genevois at 2 sites in France.
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 4 inclusion and 7 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 22 Oct 2026. 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 France. 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 Marion Beucher, PhD (+33450637032 ext. +33, mbeucher@ch-annecygenevois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of visitor restriction levels implemented in maternity wards on mothers' postnatal depressive symptoms (time frame: At discharge from hospitalization in the maternity ward, on average 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.