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

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366817
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Sorbonne University of the Pitié-Salpêtrière, Trousseau and Tenon sites, from March 20, 2020 to no longer authorize visits during the stay of mothers following childbirth. This prohibition has also been extended to spouses. This measure was guided by a concern to protect both the patients, their newborn and the entire staff of the aftermath.

The period surrounding a birth is a period of strong emotional impact with an incidence of postpartum depression estimated at 15% in the general population (1). The separation of women from their spouses during this period could expose them to greater psychological vulnerability. In addition, when they return home, the patients will be isolated from their relatives due to the quarantine, which is an additional risk factor for postpartum depression. The teams of the three maternity units of AP-HP. Sorbonne University have organized themselves to be able to respond to situations of mental vulnerability during their stay with the intervention of maternity psychologists and psychiatrists and child psychiatrists as is done in the treatment usual charge. In addition, anticipating situations of greater vulnerability linked to the health crisis, the Maternity teams decided to set up a follow-up of patients after their return home through a telephone interview with psychologists or student psychologists in Master at D10 - D12 and 6-8 weeks postpartum in order to identify patients at increased risk of postpartum depression and to set up appropriate management if necessary for these patients.

We therefore propose through this project to describe the consequences of this separation from the spouse during the postpartum stay and then with the family after returning home within the context of quarantine by assessing the incidence of post-partum depression during this sanitary crisis. A telephone interview of all the patients will be proposed on D10 - D12 and at 6-8 weeks postpartum using specific questionnaire to calculate a score of depression. This early identification will allow the establishment of an adapted psychological follow-up.


Condition or disease Intervention/treatment Phase
Post Partum Depression Behavioral: psychological assessment Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic
Actual Study Start Date : April 27, 2020
Actual Primary Completion Date : February 17, 2021
Actual Study Completion Date : February 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: women in postpartum period Behavioral: psychological assessment
psychological assessment at D10-12 and 6-8 weeks : Scheduled telephone interview using the assessment scales (EPDS, PPQ, MIBS, DAS-16) on D10-D12 and 6-8 weeks postpartum with a psychologist




Primary Outcome Measures :
  1. Proportion of patients with postpartum depression defined by an EPDS score >12 [ Time Frame: Between week 6 and week 8 ]
    assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic

  2. Proportion of patients with postpartum depression defined by an EPDS score >12 [ Time Frame: Between day 10 and day 12 ]
    assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic


Secondary Outcome Measures :
  1. Socio-demographic data [ Time Frame: Between day 1 and day 5 ]
  2. Occurrence of a maternal or fetal pathology in a previous pregnancy [ Time Frame: Between day 1 and day 5 ]
  3. Pregnant maternal pathology (hypertension, diabetes, threat of premature delivery) [ Time Frame: Between day 1 and day 5 ]
  4. Presence of psycological maternal risk factor [ Time Frame: Between day 1 and day 5 ]
    as above, maternal psychological history as vulnerability factor included : history of perinatal loss, IMG, history of post partum depression.

  5. Dyadic adjustment scale 16 (DAS-16) [ Time Frame: Between day 10 and day 12 and at between week 6 and week 8 ]
  6. Perinatal post traumatic stress disorder questionnaire (PPQ scale) [ Time Frame: Between day 10 and day 12 ]
  7. Mother to infant bonding scale (MIBS) autoquestionnaire [ Time Frame: Between day 10 and day 12 and at between week 6 and week 8 ]
  8. Measure Qualitative Interviews by Grounded theory [ Time Frame: Week 14 ]

    Participants will be asked open-ended questions about their post-partum experience in the context of COVID-19 epidemic lockdown. The interviews will be transcribed and tagged with codes which have been extracted from the data. As more data is collected codes can be regrouped into concepts and then categories. These categories are the basis of the "theory model" that emerge from the narrative of the patients.

    The verbatim of the interview will be analyzed using NVIVO software which allows a grounded theory approach.

    Using software package as Nvivo (Hutchison, 2010) with automatic analysis of the verbatim to extract codes and concepts provides a transparent account of the data and enhance study validity.

    Verbatim are download in the software, that extract repeated lexical fields the categories from the mother's narrative.

    As this is a qualitative study, there are no expected outcomes. Outcomes will be determined by the themes that arise from the post-partum interview process.




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:

-- Single pregnancy

  • Birth of a child living without hospitalisation of the child in Neonatology (outside the accommodation of the newborn in Neonatology for maternal reasons)
  • Patient speaks and understands French
  • Patient affiliated to social security
  • Major patient
  • Written consent or nonopposition if retrospectif inclusion

Exclusion Criteria:

- Protected patient or patient unable to give consent


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): NCT04366817


Locations
Layout table for location information
France
Service médecine foetale-Hôpital Trousseau
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Jean Marie JOUANNIC, PU-PH Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04366817    
Other Study ID Numbers: APHP200471
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19 - Sars-CoV2
quarantine Depression
Postpartum
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Depression, Postpartum
Depression
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications