Estimating the Prevalence of Postpartum Anxiety and Depression in the Context of the Coronavirus Disease (COVID-19) Pandemic

NCT04852757 | Completed

• 1 other identifier: PsyCOVIDUM
• Study Type: observational
• Target: 2,580
• Locations: 1 country
• Sites: 1

Brief Summary

In December 2019, infection with a new coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it conveys, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, the fear of childbirth and the postpartum period, which includes a more or less important part of anxiety-provoking uncertainty, is added to the fear of viral contamination in the perinatal period. This addition of stress factors is likely to increase the prevalence of perinatal depressive disorders and anxiety disorders, particularly the psychotraumatic experience of childbirth. Sanitary and social measures, such as quarantine, restriction of access of accompanying persons to maternity unit, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a separation of mother and child, are also likely to have psychopathological consequences. In this context, three maternity wards of the PREMA University Hospital Federation (UHF PREMA) : Groupe hospitalier Paris Saint-Joseph (GHPSJ), Louis Mourier Hospital (APHP) and Port-Royal Hospital (APHP), in partnership with the "Centre de Psychopathologie du Boulevard Brune (CPBB)" and the psychiatry department of the Louis Mourier Hospital have set up a care protocol consisting of a systematic screening offered to women following childbirth on the first day of their pregnancy, aimed at identifying those with perinatal anxiety and depressive symptoms. Women presenting symptoms are then treated according to the modalities adapted to the organization of each of these three centers.

Conditions

Depression, Postpartum

Keywords

Covid19

Outcome Measures

Primary Outcomes (1)

• Follow the evolution of the prevalence of women in immediate postpartum presenting a depressive and/or anxious symptomatology in the population of 3 maternity units in the Paris area

  Evolution during pandemic fluctuations of the proportion of women with a positive screen for anxiety and/or depressive disorders in the immediate postpartum

  2 months

Secondary Outcomes (13)

• Estimate the prevalence, in the context of a COVID-19 pandemic, of women in the immediate postpartum period presenting depressive and/or anxious symptoms (EPDS) in the population of women giving birth (in the 3 hospitals)

  Day 3

• Estimate, in the context of a COVID-19 pandemic, the prevalence of women in the immediate postpartum period presenting depressive and/or anxious symptoms (STAI-S) in the population of women giving birth (in the 3 hospitals)

  Day 3

• Estimate, in the context of a COVID-19 pandemic, the prevalence of women in the immediate postpartum period presenting depressive and/or anxious symptoms (PDEQ) in the population of women giving birth (in the 3 hospitals)

  Day 3

• Estimate, in the context of a COVID-19 pandemic, the prevalence of women in the immediate postpartum period presenting depressive and/or anxious symptoms (PDI) in the population of women giving birth (in the 3 hospitals)

  Day 3

• Estimate in the context of a COVID-19 pandemic the prevalence of women at 2 months postpartum with depressive and/or anxious symptoms (EPDS) in the population of women giving birth at the GhPSJ maternity hospital

  2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant women delivering after 24 weeks of amenorrhea between April 6, 2020 and the end of the COVID-19 epidemic in one of the three participating maternity units

You may qualify if:

• Adult pregnant women delivering after 24 weeks of amenorrhea between April 6, 2020 and the end of the COVID-19 epidemic in one of the three participating maternity units
• French speaking patient

You may not qualify if:

• Situation of fetal death or Medical Interruption of Pregnancy
• Patient under guardianship or curators
• Patient deprived of liberty
• Patient under court protection
• Patient opposing the use of his data for this research.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Depression, Postpartum; COVID-19

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elie AZRIA, Pr

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: May 25, 2021
• Primary Completion: October 31, 2022
• Study Completion: April 30, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

FR (1)