Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04852757 |
| Other study ID # |
PsyCOVIDUM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Fondation Hôpital Saint-Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
