Birth Experience During COVID-19 Confinement

Study Overview
=================
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.

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

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Other: Self-administered questionnaires


Participation Criteria
=================
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 confinementgroup : 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
confinement, birth experience, covid-19