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RecruitingNCT07653646VISIMATUpdated Oct 22, 2026

Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the Auvergne Rhone-Alpes Region (AuRA)

An interventional study of psychological assessment in Post Partum Women and Newborn Health, sponsored by Centre Hospitalier Annecy Genevois. Recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Centre Hospitalier Annecy Genevois · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 22, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
8,000
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Post Partum Women
  • Newborn Health

Keywords

  • maternity wards visiting
  • mother health
  • newborn health
03

In context

Lead sponsor

Centre Hospitalier Annecy Genevois is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8,000 participants (estimated)

Study arms

  • Other
    Intervention (additionnal psychological assessment)

    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.

    Other: psychological assessment

Interventions

  • Otherpsychological assessment

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: At discharge from hospitalization in the maternity ward, on average 48 hours

  2. 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.

    Time frame: Until discharge from hospitalization in the maternity ward, on average 48 hours.

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 22, 2026
Sites
1 site added. CH Annecy Genevois is now Not yet recruiting
Show site
  • Centre Hospitalier Annecy Genevois · Annecy, France
Oct 22, 2026
Start date
Jun 15, 2026→Jun 19, 2026 (actual)
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    1 site added. CH Annecy Genevois is now Not yet recruiting
    Show site
    • Centre Hospitalier Annecy Genevois · Annecy, France
    Start date Jun 15, 2026→Jun 19, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07653646
Lead sponsor
Centre Hospitalier Annecy Genevois
Collaborators
GIRCI Auvergne Rhone-Alpes
Responsible party
Sponsor
First posted
Jun 17, 2026
Start date
Jun 19, 2026
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Marion Beucher, PhD
Contact
mbeucher@ch-annecygenevois.fr
+33450637032 ext. +33
Noëllie FANTINATO, Midwife
principal investigator · Centre Hospitalier Annecy Genevois

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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