Post Partum DepressionCOVIDDEPERINATNCT04516668
Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression
An observational study of Post Partum Depression, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Partum Depression
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Nov 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women who were treated by the psychiatry department at Bicêtre hospital for post-partum depression between 2013 and late 2019 and their partner
Who may be able to join
- Women above 18 years old
- Who have experienced a post-partum depression between 2013 and late of 2019
- Who have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service
- Who have a child less than 7 years old (preschool age)
- Speaking and reading in french
- And their partner (above 18 years old)
- In the main analyze, only women with a indication of following psychiatric follow-up by tele-consultation (with a psychiatric follow-up at the begenning of the quarantine, who have not been follow-up by psychiatrist in hospitalization or in face to face consultation) will be analyzed
Who cannot join
- People with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)
- People with mental handicap
- People who are not able to give their consent
- People subject to protection measure
- People refusing to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation
Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.
Read the detailed description
The pandemic of COVID-19 (coronavirus desease 19) led to a strict quarantine from 15 March 2020 to 11 May 2020. Maternal depression is a current pathology , especially in the post-partum (more than 15%). The quarantine could lead to anxious and/or depressive symptoms and difficulties in parents-children bonding.
Women who have experenced post-partum period have more chance to developp subsequent depression.
Among women who have experienced post-partum depression, those who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.
- Conditions
- Post Partum Depression
- Keywords
- Post Partum Depression, Tele-consultation, COVID-19
- Medical subject headings
- Depression, Postpartum, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Hospital anxiety and depression scale (HAD)
To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation
Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case
Measured: 15 minutes
Secondary outcomes (6)
Evaluation of Edinburgh Postpartum Depression Scale (EPDS)
To compare the result of EPDS in women who have a child of less 2 years old according to a follow-up or not by tele-consultation during the quarantine
Measured: 15 minutes
Evaluation of HAD score in fathers
Anxiety and depression of fathers will be assessed with HAD scale
Measured: 15 minutes
Evaluation of EPDS in fathers
EPDS will be assessed in fathers who have a child of less than 2 years old
Measured: 15 minutes
Study of the relationship between maternals and paternals symptoms
The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptoms
Measured: 15 minutes
Study of difficuties in child during the quarantine
Look for a correlation between the difficulties in child during the quarantine describe by parents and anxiety and depression symptoms in parents The difficulties in child will be illustrated with the rate of children with difficulties describe by the parents
Measured: 15 minutes
Risk and protection factors
Description of risk factors and protection factors setting up by the family during this quarantine period
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Gressier, Dr, Principal investigator, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516668
- Sponsor's protocol ID
- APHP200878
- Acronym
- COVIDDEPERINAT
- Status last verified
- Jul 2020
- First submitted
- 17 Aug 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation
- ClinicalTrials.gov ID
- NCT04516668
- Acronym / sponsor ID
- COVIDDEPERINAT / APHP200878
- Conditions
- Post Partum Depression
- Keywords
- Post Partum Depression, Tele-consultation, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 18 Aug 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.
Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.
Detailed description
The pandemic of COVID-19 (coronavirus desease 19) led to a strict quarantine from 15 March 2020 to 11 May 2020. Maternal depression is a current pathology , especially in the post-partum (more than 15%). The quarantine could lead to anxious and/or depressive symptoms and difficulties in parents-children bonding.
Women who have experenced post-partum period have more chance to developp subsequent depression.
Among women who have experienced post-partum depression, those who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who were treated by the psychiatry department at Bicêtre hospital for post-partum depression between 2013 and late 2019 and their partner
Key inclusion criteria (7 listed)
- Women above 18 years old
- Who have experienced a post-partum depression between 2013 and late of 2019
- Who have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service
- Who have a child less than 7 years old (preschool age)
- Speaking and reading in french
Key exclusion criteria (5 listed)
- People with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)
- People with mental handicap
- People who are not able to give their consent
- People subject to protection measure
- People refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Hospital anxiety and depression scale (HAD)
Time frame: 15 minutes
To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case
6 secondary outcomes
Evaluation of Edinburgh Postpartum Depression Scale (EPDS)
Time frame: 15 minutes
Evaluation of HAD score in fathers
Time frame: 15 minutes
Evaluation of EPDS in fathers
Time frame: 15 minutes
Study of the relationship between maternals and paternals symptoms
Time frame: 15 minutes
Study of difficuties in child during the quarantine
Time frame: 15 minutes
Risk and protection factors
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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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.
Florence Gressier, Dr principal investigator
Bicêtre Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Depression, run by Assistance Publique - Hôpitaux de Paris.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence Gressier, Dr (01 45 21 27 43, florence.gressier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Hospital anxiety and depression scale (HAD) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2020.