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.
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
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.
- Conditions
- Depression, Postpartum
- 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted21 Apr 2021
- Study start25 May 2021
- Primary completion31 Oct 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie AZRIA, Pr, Principal investigator, Fondation Hôpital Saint-Joseph
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Prevalence of Postpartum Anxiety and Depression in the Context of the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04852757
- Acronym / sponsor ID
- PsyCOVIDUM / PsyCOVIDUM
- Conditions
- Depression, Postpartum
- Keywords
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,580 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Evolution during pandemic fluctuations of the proportion of women with a positive screen for anxiety and/or depressive disorders in the immediate postpartum
13 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 2 months
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
Time frame: 2 months
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
Time frame: 2 months
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
Time frame: 2 months
Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context
Time frame: 3 days to 2 months
Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context
Time frame: 3 days to 2 months
Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context
Time frame: 3 days to 2 months
Investigate factors associated with the risk of developing depressive and/or anxiety symptomatology in the COVID-19 pandemic context
Time frame: 3 days to 2 months
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)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elie AZRIA, Pr principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
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.