Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 6:59 AM
Study NCT ID:
NCT04516668
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Hospital anxiety and depression scale (HAD)', 'timeFrame': '15 minutes', 'description': 'To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation\n\nScore less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Edinburgh Postpartum Depression Scale (EPDS)', 'timeFrame': '15 minutes', 'description': 'To compare the result of EPDS in women who have a child of less 2 years old according to a follow-up or not by tele-consultation during the quarantine'}, {'measure': 'Evaluation of HAD score in fathers', 'timeFrame': '15 minutes', 'description': 'Anxiety and depression of fathers will be assessed with HAD scale'}, {'measure': 'Evaluation of EPDS in fathers', 'timeFrame': '15 minutes', 'description': 'EPDS will be assessed in fathers who have a child of less than 2 years old'}, {'measure': 'Study of the relationship between maternals and paternals symptoms', 'timeFrame': '15 minutes', 'description': 'The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptoms'}, {'measure': 'Study of difficuties in child during the quarantine', 'timeFrame': '15 minutes', 'description': 'Look for a correlation between the difficulties in child during the quarantine describe by parents and anxiety and depression symptoms in parents The difficulties in child will be illustrated with the rate of children with difficulties describe by the parents'}, {'measure': 'Risk and protection factors', 'timeFrame': '15 minutes', 'description': 'Description of risk factors and protection factors setting up by the family during this quarantine period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Partum Depression', 'Tele-consultation', 'COVID-19'], 'conditions': ['Post Partum Depression']}, 'descriptionModule': {'briefSummary': 'Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.', 'detailedDescription': 'The pandemic of COVID-19 (coronavirus desease 19) led to a strict quarantine from 15 March 2020 to 11 May 2020. Maternal depression is a current pathology , especially in the post-partum (more than 15%). The quarantine could lead to anxious and/or depressive symptoms and difficulties in parents-children bonding.\n\nWomen who have experenced post-partum period have more chance to developp subsequent depression.\n\nAmong women who have experienced post-partum depression, those who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who were treated by the psychiatry department at Bicêtre hospital for post-partum depression between 2013 and late 2019 and their partner', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen above 18 years old\n\nWho have experienced a post-partum depression between 2013 and late of 2019\n\nWho have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service\n\nWho have a child less than 7 years old (preschool age)\n\nSpeaking and reading in french\n\nAnd their partner (above 18 years old)\n\nIn the main analyze, only women with a indication of following psychiatric follow-up by tele-consultation (with a psychiatric follow-up at the begenning of the quarantine, who have not been follow-up by psychiatrist in hospitalization or in face to face consultation) will be analyzed\n\nExclusion Criteria:\n\nPeople with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)\n\nPeople with mental handicap\n\nPeople who are not able to give their consent\n\nPeople subject to protection measure\n\nPeople refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT04516668', 'acronym': 'COVIDDEPERINAT', 'briefTitle': 'Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation', 'orgStudyIdInfo': {'id': 'APHP200878'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Florence Gressier, Dr', 'role': 'CONTACT', 'email': 'florence.gressier@aphp.fr', 'phone': '01 45 21 27 43'}, {'name': 'Emmanuelle Corruble, Pr', 'role': 'CONTACT', 'email': 'emmanuelle.corruble@aphp.fr', 'phone': '01 45 21 27 43'}], 'overallOfficials': [{'name': 'Florence Gressier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bicêtre Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}