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Depression, PostpartumPsyCOVIDUMNCT04852757

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

An observational study of Depression, Postpartum, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression, Postpartum
How many people
2,580 participants
Where
1 siteFrance
Study dates
25 May 2021to 30 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

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

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

Official title: Estimating the Prevalence of Postpartum Anxiety and Depression in the Context of the COVID-19 Pandemic

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.

Read the detailed description

Screening in these three centers is based on the use of a self-administered questionnaire for the detection of depressive disorders, the Edinburgh Postnatal Depression Scale (EPDS), which allows the calculation of a score.

In addition to the EPDS, three other tools are used at the GHPSJ maternity : a questionnaire to screen for anxiety, the State-Trait Anxiety Inventory (STAI-S), and two for trauma symptoms, the Peritraumatic Dissociative Experiences Questionnaire (PDEQ) and the Peritraumatic Distress Inventory (PDI). In this center, the screening includes a second phase with a home mailing between 6 and 8 weeks after delivery: the EPDS, the STAI-S and the Impact Events Scale-Revised (IES-R), another test screening for post-traumatic stress.

Based on the protocol implemented in these three maternity hospitals, the present research project aims to estimate the prevalence of postpartum depressive disorders at different times during and after the COVID-19 pandemic. It will also aim to identify the factors associated with the occurrence of these disorders, primarily to determine the association between elements of the pandemic context and the risk of postpartum depressive and anxiety disorders.

This project, which is based on an epidemiological approach, thus aims to assess the mental health risks associated with the COVID-19 pandemic. Postpartum women are a particularly vulnerable group, especially in terms of mental health.

Indeed, 1 to 5% develop post-traumatic stress disorder during this period and 10 to 20% develop post-partum depression. Furthermore, the National Confidential Survey on Maternal Deaths (NCSMD) shows that suicide is now the leading cause of maternal death in France (i.e., death occurring between conception and the first year following birth), before postpartum hemorrhage and before preeclampsia (data not yet published). From pooled English, Dutch, and French data, we observe that 36% of maternal deaths occurring between conception and the first year postpartum are deaths by suicide.

The COVID-19 pandemic and the associated measures that went as far as confining the population were very likely to increase the factors favouring the occurrence of mental health impairment in the general population, but perhaps even more so in certain at-risk groups such as postpartum women.

The pandemic context, whether through the fears associated with the viral infection for oneself or one's family, or through the consequences of the exceptional measures put in place in many countries to limit viral circulation, has had an effect on the general population and on the population of women in pregnancy, in different contexts. To date and to our knowledge, there is no data that would allow us to know the impact that this context may have had on the mental health of pregnant women in France. Moreover, there are no studies, either in France or elsewhere, on the impact of this pandemic context on the prevalence of psychological disorders in the postpartum period. However, this period is already a time of particular psychological vulnerability, a time when the risk of maternal suicide is at its highest. It is moreover reasonable to think that the pandemic impact and the general and local measures that accompany it may have an even greater impact during this postpartum period. The measures taken to prevent and protect against viral dissemination have had the effect of completely closing most maternity services to fathers and thus depriving mothers, totally or partially, of social and marital support and, in some situations, of physical proximity to their children, all of which are risk factors for postpartum depression.

In the perinatal context, it has also been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression.

Keywords
Covid19
Medical subject headings
Depression, Postpartum, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 months

Secondary outcomes (13)
  1. 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)

    Prevalence of women with immediate postpartum EPDS >10.

    Measured: Day 3

  2. 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)

    Prevalence of women with immediate postpartum (STAI-S) > 45

    Measured: Day 3

  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)

    Prevalence of women with immediate postpartum Peritraumatic Dissociative Experiences Questionnaire (PDEQ) > 15

    Measured: Day 3

  4. 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)

    Prevalence of women with immediate postpartum Peritraumatic Distress Inventory scale (PDI) > 15

    Measured: Day 3

  5. 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

    Prevalence of women with immediate postpartum EPDS >10

    Measured: 2 months

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

    Prevalence of women with immediate postpartum (STAI-S) > 45

    Measured: 2 months

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

    Prevalence of women with immediate postpartum Peritraumatic Dissociative Experiences Questionnaire (PDEQ) > 15

    Measured: 2 months

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

    Prevalence of women with immediate postpartum Impact Events Scale-Revised (IES-R) > 12

    Measured: 2 months

  9. Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context

    Measure of association between COVID-19 infection and risk of having a score above the cutoff

    Measured: 3 days to 2 months

  10. Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context

    Measure of association between time of delivery (reflecting exposure to general and local quarantine, as well as risk of viral infection) and risk of having a score above the cutoff

    Measured: 3 days to 2 months

  11. Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context

    Measure of association between maternal socio-familial isolation in the postpartum period and the risk of having a score above the cutoff

    Measured: 3 days to 2 months

  12. Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context

    Measure of association between mother-child separation in the postpartum period and risk of having a score above the cutoff

    Measured: 3 days to 2 months

  13. Comparison of the prevalence of anxiety and depressive disorders among women not infected with SARS-CoV2 in PsyCOVIDUM with those infected in the COROPREG study (COVID-19 and pregnancy: a population-based cohort of women and newborns)

    Measuring the impact of maternal COVID-19 infection on anxiety-depressive symptomatology.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start25 May 2021
  3. Primary completion31 Oct 2022
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2,580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04852757
Sponsor's protocol ID
PsyCOVIDUM
Acronym
PsyCOVIDUM
Status last verified
Sep 2023
First submitted
20 Apr 2021
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, Postpartum, run by Fondation Hôpital Saint-Joseph at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 2 months). 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 13 Sep 2023.

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