Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic Short Title : Isolement and Childbirth: Psychological Impact : Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic

The main objective of this study is to assess the emotional impact of the separation of women from their spouses following childbirth and their family isolation when returning home within the context of quarantine due to the COVID epidemic.The secondary objectives are:To identify the factors of greatest vulnerability or resilience of the patients in the immediate postpartum period (6-8 weeks after delivery).To evaluate the impact of quarantine on the couples (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS) at D10-D12 postpartum and at 6-8 weeks postpartum.Recording of all interviews allowing a qualitative study of the verbatim by the use of N-Vivo software allowing the analysis of unstructured and qualitative data.The primary endpoint will be the proportion of patients with postpartum depression defined by EPDS score >12 at D10-12 and 6-8 weeks postpartum. The EPDS relies on 10 specific items which allows the calculation of a depression score. A threshold > 12 is used in research to define the existence of depressive symptoms. For research, the score can be used as a continuous variable or in class with the threshold value 12.The secondary end points will be:to study factors of greatest vulnerability or resilience of the patients will be studied:Socio-economic datamaternal or fetal pathology during previous pregnanciesassociated pregnancy pathologyMaternal psychologic historyto describe the impact on the couple (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS):Dyadic Adjustment scale 16 (DAS-16). Revised scale was developed to assess dyadic adjustment in marriage.Perinatal Posttraumatic Stress Disorder Questionnaire (PPQ). This self-questionnaire makes it possible to assess the post-traumatic reactions of parents faced with the birth of a child presenting a high perinatal risk.Mother-to-Infant Bonding Scale (MIBS): Auto questionnaire, initially developed with a view to researching disturbances in maternal feelings towards the newborn. The scores range from 0 to 24, a high score being in favor of a mother-child bond disorder.Automated psycho-linguistic analysis of the interviews using the N Vivo software. This software allows an automated study of the verbatim allowing a qualitative analysis of prosody and to identify emotional profiles and thus to identify situations of anxiety, stress and depression.The study population will consist of patients with delivery of a child and:Singleton pregnancyAlive child without hospitalization of the child in NICUPatient speaking and understanding FrenchMajor patientDuration of inclusion will be 2 months The Inclusion visit will take place during hospitalization in post-partum units, signed consent informed will be collected by a qualified person (medical doctor or midwife) before inclusion. Each week, these forms will be sent to the study psychologist referent in each of the 3 Maternity units.Research follow-up visits:Scheduled telephone interview using the assessment scales described above on D10-D12 and 6-8 weeks postpartum with a psychologist or an M2 psychology student under the responsibility of a maternity psychologist. A reminder system is provided by sending an SMS / email 48 hours before the scheduled call. In the event of a missed call, a re-call is scheduled on the same day or the next day (the SMS / email sent to patients indicates this reminder mode in the event of unavailability during the first call).During this call, a semi-structured interview is carried out with EPDS score, DAS-16 scale, PPQ and MIBS questionnaire, and a recording for analysis of unstructured and qualitative data.When EPDS score> 12: proposal for psychological follow-up in accordance with current standard of care in the event of postpartum depression.For scores <12, the possibility of a further interview with a psychologist, apart from the study, is formulated.Telephone interview at 6-8 weeks with psychologist including, as previously described, a semi-structured interview with EPDS score, DAS-16 scale and MIBS questionnaire and a recording for analysis of unstructured and qualitative data When EPDS score> 12: proposal for psychological follow-up in accordance with current standard of care in the event of postpartum depression.For scores <12, the possibility of a further interview with a psychologist is formulated.The patients were informed of the recording of the calls. In case of refusal, the calls are not recorded and only the semi-structured interview is carried out with EPDS score and DAS-16 scale and PPQ and MIBS questionnaire.Sample size justification The inclusion of 452 women will allow to detect at least a 5 points change in the proportion of postpartum depression during COVID pandemic period compared to the expected/usual proportion of 15% (15 vs. 20%) with 80% of power, considering two-sided alpha risk of 5% and 5% of dropout..

Medienart:	Klinische Studie

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	ClinicalTrials.gov - (2022) vom: 30. Juni Zur Gesamtaufnahme - year:2022

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 COVID-19 Depression Depression, Postpartum Medical Condition: Post Partum Depression Recruitment Status: Completed Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: April 29, 2020, Last downloaded: ClinicalTrials.gov processed this data on July 04, 2022, Last updated: July 06, 2022

Study ID:	NCT04366817 APHP200471
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PPN (Katalog-ID):	CTG003375285