Postpartum DepressionCONFINENCT04348929
Birth Experience During COVID-19 Confinement
A study testing Self-administered questionnaires in people with Postpartum Depression, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Self-administered questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 927 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2020to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)
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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- Self-administered questionnaires
- Keywords
- confinement, birth experience, covid-19
- Medical subject headings
- Depression, Postpartum, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnairesOther
Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home)
| Study group | Role | What they receive |
|---|---|---|
| Confinement group | Experimental | Delivery during covid-19 confinement period Receives: Other: Self-administered questionnaires |
| Control group | Other | Delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate) Receives: Other: Self-administered questionnaires |
| Epidemic group | Other | Delivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate) Receives: Other: Self-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)
Measured: through study completion, an average of 16 months
Secondary outcomes (7)
"Labor Agentry Scale questionnaire" score at two months after birth
Measured: 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
Measured: 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
Measured: through study completion, an average of 16 months
Breastfeeding statement at two months after birth
Measured: through study completion, an average of 16 months
"SF-12 Quality of life questionnaire" score at two months after birth
Measured: through study completion, an average of 16 months
"SF-12 Quality of life questionnaire" score in immediate post-partum
Measured: through study completion, an average of 16 months
Diagnosis of post-natal depression (made by a specialist)
Measured: through study completion, an average of 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start16 Apr 2020
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERTHOLDT Charline, Central Hospital, Nancy, France
- Investigators
- Charline BERTHOLDT, Study chair, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348929
- Sponsor's protocol ID
- 2020-A00881-38
- Acronym
- CONFINE
- Status last verified
- Feb 2024
- First submitted
- 10 Apr 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33303470
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)
- ClinicalTrials.gov ID
- NCT04348929
- Acronym / sponsor ID
- CONFINE / 2020-A00881-38
- Conditions
- Postpartum Depression
- Keywords
- confinement, birth experience, covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Confinement group | Experimental | Other: Self-administered questionnairesDelivery during covid-19 confinement period |
| Control group | Other | Other: Self-administered questionnairesDelivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate) |
| Epidemic group | Other | Other: Self-administered questionnairesDelivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered questionnairesSelf-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home) | Other | Confinement group, Control group, Epidemic group |
Primary outcome
"Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)
Time frame: through study completion, an average of 16 months
7 secondary outcomes
"Labor Agentry Scale questionnaire" score at two months after birth
Time frame: through study completion, an average of 16 months
Edinburg Postnatale Depression Scale questionnaire" score at two months after birth
Time frame: through study completion, an average of 16 months
"Impact of Event Scale - Revised questionnaire" score at two months after birth
Time frame: through study completion, an average of 16 months
Breastfeeding statement at two months after birth
Time frame: through study completion, an average of 16 months
"SF-12 Quality of life questionnaire" score at two months after birth
Time frame: through study completion, an average of 16 months
"SF-12 Quality of life questionnaire" score in immediate post-partum
Time frame: through study completion, an average of 16 months
Diagnosis of post-natal depression (made by a specialist)
Time frame: through study completion, an average of 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 33303470Bertholdt 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charline BERTHOLDT study chair
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered questionnaires in people with Postpartum Depression, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay) (time frame: through study completion, an average of 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.