Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women (PsyCOVIDUMGEN)
Primary Purpose
Perinatal Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients
Sponsored by
About this trial
This is an interventional other trial for Perinatal Depression
Eligibility 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
Sites / Locations
- Maternité Louis Mourier
- Groupe Hospitalier Paris Saint-Joseph
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
The procedure involves taking a total of 12 ml of blood.
Outcomes
Primary Outcome Measures
Role of genetic factors involved in maternally diagnosed perinatal depression by genome-wide association analysis
This outcome corresponds to the biobank built up from the blood samples of the included female volunteers.
Secondary Outcome Measures
Full Information
NCT ID
NCT05175755
First Posted
December 30, 2021
Last Updated
August 17, 2023
Sponsor
Fondation Hôpital Saint-Joseph
1. Study Identification
Unique Protocol Identification Number
NCT05175755
Brief Title
Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
Acronym
PsyCOVIDUMGEN
Official Title
Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
The procedure involves taking a total of 12 ml of blood.
Intervention Type
Other
Intervention Name(s)
Patients
Intervention Description
The procedure involves taking a total of 12 ml of blood.
Primary Outcome Measure Information:
Title
Role of genetic factors involved in maternally diagnosed perinatal depression by genome-wide association analysis
Description
This outcome corresponds to the biobank built up from the blood samples of the included female volunteers.
Time Frame
Day 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elie AZRIA, MD
Phone
144127570
Ext
+33
Email
eazria@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Helene BEAUSSIER, PharmD, PhD
Phone
144127883
Ext
+33
Email
crc@ghpsj.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie AZRIA, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternité Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline DUBERTRET, MD
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie P AZRIA
12. IPD Sharing Statement
Citations:
PubMed Identifier
32091533
Citation
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Results Reference
background
PubMed Identifier
32151335
Citation
Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
Results Reference
background
PubMed Identifier
32505805
Citation
Kayem G, Lecarpentier E, Deruelle P, Bretelle F, Azria E, Blanc J, Bohec C, Bornes M, Ceccaldi PF, Chalet Y, Chauleur C, Cordier AG, Desbriere R, Doret M, Dreyfus M, Driessen M, Fermaut M, Gallot D, Garabedian C, Huissoud C, Luton D, Morel O, Perrotin F, Picone O, Rozenberg P, Sentilhes L, Sroussi J, Vayssiere C, Verspyck E, Vivanti AJ, Winer N, Alessandrini V, Schmitz T. A snapshot of the Covid-19 pandemic among pregnant women in France. J Gynecol Obstet Hum Reprod. 2020 Sep;49(7):101826. doi: 10.1016/j.jogoh.2020.101826. Epub 2020 Jun 4.
Results Reference
background
PubMed Identifier
32213786
Citation
Rasmussen SA, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and Pregnancy: Responding to a Rapidly Evolving Situation. Obstet Gynecol. 2020 May;135(5):999-1002. doi: 10.1097/AOG.0000000000003873.
Results Reference
background
PubMed Identifier
32531146
Citation
Walker KF, O'Donoghue K, Grace N, Dorling J, Comeau JL, Li W, Thornton JG. Maternal transmission of SARS-COV-2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis. BJOG. 2020 Oct;127(11):1324-1336. doi: 10.1111/1471-0528.16362. Epub 2020 Jul 22.
Results Reference
background
PubMed Identifier
32034840
Citation
Shigemura J, Ursano RJ, Morganstein JC, Kurosawa M, Benedek DM. Public responses to the novel 2019 coronavirus (2019-nCoV) in Japan: Mental health consequences and target populations. Psychiatry Clin Neurosci. 2020 Apr;74(4):281-282. doi: 10.1111/pcn.12988. Epub 2020 Feb 23. No abstract available.
Results Reference
background
PubMed Identifier
31698012
Citation
Achtyes E, Keaton SA, Smart L, Burmeister AR, Heilman PL, Krzyzanowski S, Nagalla M, Guillemin GJ, Escobar Galvis ML, Lim CK, Muzik M, Postolache TT, Leach R, Brundin L. Inflammation and kynurenine pathway dysregulation in post-partum women with severe and suicidal depression. Brain Behav Immun. 2020 Jan;83:239-247. doi: 10.1016/j.bbi.2019.10.017. Epub 2019 Nov 5.
Results Reference
background
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Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
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