We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women (PsyCOVIDUMGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05175755
Recruitment Status : Not yet recruiting
First Posted : January 4, 2022
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

In December 2019, infection with a novel coronavirus 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 carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences.

Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression.

In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals.

This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.


Condition or disease Intervention/treatment Phase
Perinatal Depression Other: Patients Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
Estimated Study Start Date : December 25, 2022
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : December 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients
The procedure involves taking a total of 12 ml of blood.
Other: Patients
The procedure involves taking a total of 12 ml of blood.




Primary Outcome Measures :
  1. Role of genetic factors involved in maternally diagnosed perinatal depression by genome-wide association analysis [ Time Frame: Day 3 ]
    This outcome corresponds to the biobank built up from the blood samples of the included female volunteers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant woman whose age is ≥ 18 years, delivering after 34 SA in one of the two participating maternity hospitals that responded to the EPDS
  • Accepting a blood sample
  • EPDS score less than 8 or greater than 11
  • French-speaking woman
  • Woman affiliated with a health insurance plan
  • Free, informed, written consent was obtained from the woman

Exclusion Criteria:

  • Fetal death or medical termination of pregnancy
  • Women under guardianship or trusteeship
  • Woman deprived of liberty
  • Woman under court protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05175755


Contacts
Layout table for location contacts
Contact: Elie AZRIA, MD 144127570 ext +33 eazria@ghpsj.fr
Contact: Helene BEAUSSIER, PharmD, PhD 144127883 ext +33 crc@ghpsj.fr

Locations
Layout table for location information
France
Maternité Louis Mourier
Colombes, France, 92700
Contact: Caroline DUBERTRET, MD         
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Contact: Elie P AZRIA         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Principal Investigator: Elie AZRIA, MD Groupe Hospitalier Paris Saint Joseph
Publications:

Layout table for additonal information
Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT05175755    
Other Study ID Numbers: PsyCOVIDUMGEN
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Asphyxia Neonatorum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases