Clinical trial NCT04348929: Birth Experience During COVID-19 Confinement
Official title: Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: confinement
birth experience
covid-19
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 927
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

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

Primary outcomes:
measure: "Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)
timeFrame: through study completion, an average of 16 months
Secondary outcomes:
measure: "Labor Agentry Scale questionnaire" score at two months after birth
timeFrame: through study completion, an average of 16 months
measure: Edinburg Postnatale Depression Scale questionnaire" score at two months after birth
timeFrame: through study completion, an average of 16 months
measure: "Impact of Event Scale - Revised questionnaire" score at two months after birth
timeFrame: through study completion, an average of 16 months
measure: Breastfeeding statement at two months after birth
timeFrame: through study completion, an average of 16 months
measure: "SF-12 Quality of life questionnaire" score at two months after birth
timeFrame: through study completion, an average of 16 months
measure: "SF-12 Quality of life questionnaire" score in immediate post-partum
timeFrame: through study completion, an average of 16 months
measure: Diagnosis of post-natal depression (made by a specialist)
timeFrame: through study completion, an average of 16 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Charline BERTHOLDT
role: STUDY_CHAIR
References:
citation: 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.