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Birth Experience During COVID-19 Confinement (CONFINE)

Primary Purpose

Postpartum Depression

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Self-administered questionnaires

About this trial

This is an interventional screening trial for Postpartum Depression focused on measuring confinement, birth experience, covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Specific inclusion criteria according to the group For "confinement"group : Delivery during covid-19 confinement period

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

Sites / Locations

Centre Hospitalier Régional Universitaire de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Confinement group

Control group

Epidemic group

Arm Description

Delivery during covid-19 confinement period

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

To detect suspicion of Post-Partum Depression

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

To detect suspicion of Post traumatic stress syndrome

Breastfeeding statement at two months after birth

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

"SF-12 Quality of life questionnaire" score in immediate post-partum

Diagnosis of post-natal depression (made by a specialist)

Full Information

NCT ID

NCT04348929

First Posted

April 10, 2020

Last Updated

February 6, 2023

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT04348929

Brief Title

Birth Experience During COVID-19 Confinement

Acronym

CONFINE

Official Title

Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 16, 2020 (Actual)

Primary Completion Date

August 16, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: To compare, at two months post-partum, the maternal sense of control during childbirth between the three groups. 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. 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. To compare, at two months of post-partum, the breastfeeding between the three groups. To compare, at two months of post-partum, the quality of life (SF-12) between the three groups. To compare the evolution of quality of life at two months of post-partum between the three groups. To compare the rate of post-natal depression between the three groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Depression

Keywords

confinement, birth experience, covid-19

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

927 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Confinement group

Arm Type

Experimental

Arm Description

Delivery during covid-19 confinement period

Arm Title

Control group

Arm Type

Other

Arm Description

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

Arm Title

Epidemic group

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Self-administered questionnaires

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame