Birth Experience During COVID-19 Confinement (CONFINE)

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Other: Self-administered questionnaires

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.

• Study Type: Interventional
• Enrollment (Actual): 927
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Centre Hospitalier Régional Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Confinement group; Delivery during covid-19 confinement period	Other: 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)
Other: Control group; Delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate)	Other: 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)
Other: Epidemic group; 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; Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
"Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)	through study completion, an average of 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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	To detect suspicion of Post-Partum Depression	through study completion, an average of 16 months
"Impact of Event Scale - Revised questionnaire" score at two months after birth	To detect suspicion of Post traumatic stress syndrome	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
"SF-12 Quality of life questionnaire" score in immediate post-partum		through study completion, an average of 16 months
Diagnosis of post-natal depression (made by a specialist)		through study completion, an average of 16 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Charline BERTHOLDT, Centre Hospitalier Régional Universitaire de Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: covid-19; confinement; birth experience
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Mood Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; COVID-19; Depression, Postpartum
• Other Study ID Numbers: 2020-A00881-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data generated during this study will be made available via CIC-EC, CHRU Nancy, Nancy- FRANCE in accordance with protocol promotor. Data obtained from this study will be deposited at CIC-EC Nancy where they will be maintained for a minimum of 15 years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No