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

Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the AuRA Region

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07653646
Acronym
VISIMAT
Enrollment
8000
Registered
2026-06-17
Start date
2026-06-15
Completion date
2028-06-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Health, Post Partum Women

Keywords

maternity wards visiting, mother health, newborn health

Brief 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.

Interventions

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.

Sponsors

Centre Hospitalier Annecy Genevois
Lead SponsorOTHER
GIRCI Auvergne Rhone-Alpes
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of visitor restriction levels implemented in maternity wards on mothers' postnatal depressive symptomsAt discharge from hospitalization in the maternity ward, on average 48 hoursThe 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.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.

Countries

France

Contacts

CONTACTMarion Beucher, PhD
mbeucher@ch-annecygenevois.fr+33450637032
PRINCIPAL_INVESTIGATORNoëllie FANTINATO, Midwife

Centre Hospitalier Annecy Genevois

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026