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Birth Experience During COVID-19 Confinement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04348929
Acronym
CONFINE
Enrollment
927
Registered
2020-04-16
Start date
2020-04-16
Completion date
2023-07-21
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

Keywords

confinement, birth experience, covid-19

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.

Interventions

Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home)

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Labor Agentry Scale questionnaire score in immediate post-partum (duration of hospital stay)through study completion, an average of 16 months

Secondary

MeasureTime frameDescription
Edinburg Postnatale Depression Scale questionnaire score at two months after birththrough study completion, an average of 16 monthsTo detect suspicion of Post-Partum Depression
Impact of Event Scale - Revised questionnaire score at two months after birththrough study completion, an average of 16 monthsTo detect suspicion of Post traumatic stress syndrome
Breastfeeding statement at two months after birththrough study completion, an average of 16 months
Labor Agentry Scale questionnaire score at two months after birththrough study completion, an average of 16 months
SF-12 Quality of life questionnaire score in immediate post-partumthrough study completion, an average of 16 months
Diagnosis of post-natal depression (made by a specialist)through study completion, an average of 16 months
SF-12 Quality of life questionnaire score at two months after birththrough study completion, an average of 16 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026