Trials / Completed
CompletedNCT04348929
Birth Experience During COVID-19 Confinement
Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 927 (actual)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2020-04-16
- Primary completion
- 2023-07-21
- Completion
- 2023-07-21
- First posted
- 2020-04-16
- Last updated
- 2024-02-08
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04348929. Inclusion in this directory is not an endorsement.