Birth Experience During COVID-19 Confinement

NCT ID: NCT04348929

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 927 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2023-07-21

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.

Detailed Description

The primary objective is to compare, in immediate post-partum, the maternal sense of control during childbirth between a group of women who gave birth during confinement ("confinement" group) versus a group of women who gave birth after confinement but in the context of epidemic ("epidemic" group) versus a group of control women ("control" group; excluding confinement and context of epidemic).

The secondary objectives are:

1. To compare, at two months post-partum, the maternal sense of control during childbirth between the three groups.

2. To compare, at two months of post-partum, scoring of self-questionnaire Edinburg Postnatale Depression Scale (EPDS) for the post-natal depression between the three groups.

3. To compare at two months of post-partum, scoring of self-questionnaire Impact of Event Scale - Revised (IES-R) for posttraumatic stress disorder, between the three groups.

4. To compare, at two months of post-partum, the breastfeeding between the three groups.

5. To compare, at two months of post-partum, the quality of life (SF-12) between the three groups.

6. To compare the evolution of quality of life at two months of post-partum between the three groups.

7. To compare the rate of post-natal depression between the three groups.

Conditions

Postpartum Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Confinement group

Delivery during covid-19 confinement period

Group Type: EXPERIMENTAL

Self-administered questionnaires

Intervention Type: OTHER

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

Control group

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

Group Type: OTHER

Self-administered questionnaires

Intervention Type: OTHER

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

Epidemic group

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

Group Type: OTHER

Self-administered questionnaires

Intervention Type: OTHER

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

Interventions

Self-administered questionnaires

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

BERTHOLDT Charline

Principal Investigator (obstetrician-gynecologist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charline BERTHOLDT

Role: STUDY_CHAIR

Central Hospital, Nancy, France

Locations

Centre Hospitalier Régional Universitaire de Nancy

Nancy, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33303470 (View on PubMed)

Other Identifiers

2020-A00881-38

Identifier Type: -

Identifier Source: org_study_id