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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Confinement group | Experimental | Delivery during covid-19 confinement period |
|
| Control group | Other | Delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate) |
|
| Epidemic group | Other | Delivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered questionnaires | Other | Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home) |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Charline BERTHOLDT | Central Hospital, Nancy, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Nancy | Nancy | 54000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33303470 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |