Birth Experience During COVID-19 Confinement

NCT04348929 | Completed

• 1 other identifier: 2020-A00881-38
• Study Type: interventional
• Target: 927
• Locations: 1 country
• Sites: 1

Brief Summary

Different studies have demonstrated that the absence of companionship during labor and childbirth may be responsible for a negative birth experience, an increased risk of postnatal depression and/or post traumatic stress disorders. These situation may also have a negative impact on mother-child interaction, on marital and family relationship and on the rate of maternal suicide in postpartum. However, these previous results cannot be extrapolated in the current context where the absence of the companionship is imposed by the confinement framework. The objective of the CONFINE study is to assess, for the first time, the birth experience of women in the context of limited social support in the immediate post-partum period due to confinement, as well as the associated over-risk of mental disorders, compared to a post-partum without social restriction.

Conditions

Postpartum Depression

Keywords

confinement; birth experience; covid-19

Outcome Measures

Primary Outcomes (1)

• "Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)

  through study completion, an average of 16 months

Secondary Outcomes (7)

• "Labor Agentry Scale questionnaire" score at two months after birth

  through study completion, an average of 16 months

• Edinburg Postnatale Depression Scale questionnaire" score at two months after birth

  through study completion, an average of 16 months

• "Impact of Event Scale - Revised questionnaire" score at two months after birth

  through study completion, an average of 16 months

• Breastfeeding statement at two months after birth

  through study completion, an average of 16 months

• "SF-12 Quality of life questionnaire" score at two months after birth

  through study completion, an average of 16 months

Study Arms (3)

Confinement group

EXPERIMENTAL

Delivery during covid-19 confinement period

Other: Self-administered questionnaires

Control group

OTHER

Delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate)

Other: Self-administered questionnaires

Epidemic group

OTHER

Delivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate)

Other: Self-administered questionnaires

Interventions

Self-administered questionnaires OTHER

Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home)

Confinement group; Control group; Epidemic group

Eligibility Criteria

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

You may qualify if:

• Woman who is \>= 18 years old
• Woman having just given birth from 37 weeks of gestation (singleton pregnancy)
• Woman affiliated to a social security
• Woman with a level of understanding of written French sufficient to answer the questionnaires.
• Woman having received complete information on the organization of the research and having given her informed consent in written form.
• For "epidemic" group: Delivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate)
• For "control" group: Start of pregnancy after confinement and delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate)

You may not qualify if:

• Major mentioned in articles L.1121-6 and L-1121-8 of Health Public Code.
• Woman with psychiatric disorders such as depressive syndrome
• Woman considered positive for covid-19 and treated as such at the time of delivery (regardless of test result)
• Newborn with congenital abnormalities
• Stillbirth

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54000, France

Location

Related Publications (1)

• Bertholdt C, Epstein J, Banasiak C, Ligier F, Dahlhoff S, Olieric MF, Mottet N, Beaumont M, Morel O. Birth experience during COVID-19 confinement (CONFINE): protocol for a multicentre prospective study. BMJ Open. 2020 Dec 10;10(12):e043057. doi: 10.1136/bmjopen-2020-043057.

  PMID: 33303470 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; COVID-19

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charline BERTHOLDT

  Central Hospital, Nancy, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (obstetrician-gynecologist)

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 16, 2020
• Study Start: April 16, 2020
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)