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

NCT07653646 | Not Yet Recruiting

• 1 other identifier: 24-08
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Women; Newborn Health

Keywords

maternity wards visiting; mother health; newborn health

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

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

Study Arms (1)

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.

Other: psychological assessment

Interventions

psychological assessment OTHER

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.

Intervention (additionnal psychological assessment)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All patients admitted to the maternity ward with their newborn baby or babies will be invited to take part in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• GIRCI Auvergne Rhone-Alpes: collaborator

Study Sites (1)

CH Annecy Genevois

Épagny, Auvergne-Rhône-Alpes, 74370, France

Location

Study Officials

• Noëllie FANTINATO, Midwife

  Centre Hospitalier Annecy Genevois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Beucher, PhD

CONTACT

+33450637032; mbeucher@ch-annecygenevois.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)