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

NCT04366817 | Completed

• 1 other identifier: APHP200471
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Depression

Keywords

COVID-19 - Sars-CoV2; quarantine Depression; Postpartum

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with postpartum depression defined by an EPDS score >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

  Between week 6 and week 8

• Proportion of patients with postpartum depression defined by an EPDS score >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

  Between day 10 and day 12

Secondary Outcomes (8)

• Socio-demographic data

  Between day 1 and day 5

• Occurrence of a maternal or fetal pathology in a previous pregnancy

  Between day 1 and day 5

• Pregnant maternal pathology (hypertension, diabetes, threat of premature delivery)

  Between day 1 and day 5

• Presence of psycological maternal risk factor

  Between day 1 and day 5

• Dyadic adjustment scale 16 (DAS-16)

  Between day 10 and day 12 and at between week 6 and week 8

Study Arms (1)

women in postpartum period

EXPERIMENTAL

Behavioral: psychological assessment

Interventions

psychological assessment BEHAVIORAL

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

women in postpartum period

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \-- 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

You may not qualify if:

• \- Protected patient or patient unable to give consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service médecine foetale-Hôpital Trousseau

Paris, 75012, France

Location

Related Publications (1)

• Viaux-Savelon S, Maurice P, Rousseau A, Leclere C, Renout M, Berlingo L, Cohen D, Jouannic JM. Impact of COVID-19 lockdown on maternal psychological status, the couple's relationship and mother-child interaction: a prospective study. BMC Pregnancy Childbirth. 2022 Sep 26;22(1):732. doi: 10.1186/s12884-022-05063-6.

  PMID: 36163044 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jean Marie JOUANNIC, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: April 27, 2020
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

FR (1)