Post Partum DepressionCOVMUMNCT04366817
Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic Short Title : Isolement and Childbirth: Psychological Impact
A study testing psychological assessment in people with Post Partum Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- psychological assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 17 Feb 2021
- 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
- -- Single pregnancy
- Birth of a child living without hospitalisation of the child in Neonatology (outside the accommodation of the newborn in Neonatology for maternal reasons)
- Patient speaks and understands French
- Patient affiliated to social security
- Major patient
- Written consent or nonopposition if retrospectif inclusion
Who cannot join
- Protected patient or patient unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic
The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Sorbonne University of the Pitié-Salpêtrière, Trousseau and Tenon sites, from March 20, 2020 to no longer authorize visits during the stay of mothers following childbirth. This prohibition has also been extended to spouses. This measure was guided by a concern to protect both the patients, their newborn and the entire staff of the aftermath.
The period surrounding a birth is a period of strong emotional impact with an incidence of postpartum depression estimated at 15% in the general population (1). The separation of women from their spouses during this period could expose them to greater psychological vulnerability. In addition, when they return home, the patients will be isolated from their relatives due to the quarantine, which is an additional risk factor for postpartum depression. The teams of the three maternity units of AP-HP. Sorbonne University have organized themselves to be able to respond to situations of mental vulnerability during their stay with the intervention of maternity psychologists and psychiatrists and child psychiatrists as is done in the treatment usual charge. In addition, anticipating situations of greater vulnerability linked to the health crisis, the Maternity teams decided to set up a follow-up of patients after their return home through a telephone interview with psychologists or student psychologists in Master at D10 - D12 and 6-8 weeks postpartum in order to identify patients at increased risk of postpartum depression and to set up appropriate management if necessary for these patients.
We therefore propose through this project to describe the consequences of this separation from the spouse during the postpartum stay and then with the family after returning home within the context of quarantine by assessing the incidence of post-partum depression during this sanitary crisis. A telephone interview of all the patients will be proposed on D10 - D12 and at 6-8 weeks postpartum using specific questionnaire to calculate a score of depression. This early identification will allow the establishment of an adapted psychological follow-up.
Read the detailed description
The main objective of this study is to assess the emotional impact of the separation of women from their spouses following childbirth and their family isolation when returning home within the context of quarantine due to the COVID epidemic.
The secondary objectives are:
- To identify the factors of greatest vulnerability or resilience of the patients in the immediate postpartum period (6-8 weeks after delivery).
- To evaluate the impact of quarantine on the couples (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS) at D10-D12 postpartum and at 6-8 weeks postpartum.
- Recording of all interviews allowing a qualitative study of the verbatim by the use of N-Vivo software allowing the analysis of unstructured and qualitative data.
The primary endpoint will be the proportion of patients with postpartum depression defined by EPDS score >12 at D10-12 and 6-8 weeks postpartum. The EPDS relies on 10 specific items which allows the calculation of a depression score. A threshold > 12 is used in research to define the existence of depressive symptoms. For research, the score can be used as a continuous variable or in class with the threshold value 12.
The secondary end points will be:
- to study factors of greatest vulnerability or resilience of the patients will be studied:
- Socio-economic data
- maternal or fetal pathology during previous pregnancies
- associated pregnancy pathology
- Maternal psychologic history
- to describe the impact on the couple (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS):
- Dyadic Adjustment scale 16 (DAS-16). Revised scale was developed to assess dyadic adjustment in marriage.
- Perinatal Posttraumatic Stress Disorder Questionnaire (PPQ). This self-questionnaire makes it possible to assess the post-traumatic reactions of parents faced with the birth of a child presenting a high perinatal risk.
- Mother-to-Infant Bonding Scale (MIBS): Auto questionnaire, initially developed with a view to researching disturbances in maternal feelings towards the newborn. The scores range from 0 to 24, a high score being in favor of a mother-child bond disorder.
- Automated psycho-linguistic analysis of the interviews using the N Vivo software. This software allows an automated study of the verbatim allowing a qualitative analysis of prosody and to identify emotional profiles and thus to identify situations of anxiety, stress and depression.
The study population will consist of patients with delivery of a child and:
- Singleton pregnancy
- Alive child without hospitalization of the child in NICU
- Patient speaking and understanding French
- Major patient
Duration of inclusion will be 2 months The Inclusion visit will take place during hospitalization in post-partum units, signed consent informed will be collected by a qualified person (medical doctor or midwife) before inclusion. Each week, these forms will be sent to the study psychologist referent in each of the 3 Maternity units.
Research follow-up visits:
Scheduled telephone interview using the assessment scales described above on D10-D12 and 6-8 weeks postpartum with a psychologist or an M2 psychology student under the responsibility of a maternity psychologist. A reminder system is provided by sending an SMS / email 48 hours before the scheduled call. In the event of a missed call, a re-call is scheduled on the same day or the next day (the SMS / email sent to patients indicates this reminder mode in the event of unavailability during the first call).
During this call, a semi-structured interview is carried out with EPDS score, DAS-16 scale, PPQ and MIBS questionnaire, and a recording for analysis of unstructured and qualitative data.
When EPDS score> 12: proposal for psychological follow-up in accordance with current standard of care in the event of postpartum depression.
For scores <12, the possibility of a further interview with a psychologist, apart from the study, is formulated.
Telephone interview at 6-8 weeks with psychologist including, as previously described, a semi-structured interview with EPDS score, DAS-16 scale and MIBS questionnaire and a recording for analysis of unstructured and qualitative data When EPDS score> 12: proposal for psychological follow-up in accordance with current standard of care in the event of postpartum depression.
For scores <12, the possibility of a further interview with a psychologist is formulated.
The patients were informed of the recording of the calls. In case of refusal, the calls are not recorded and only the semi-structured interview is carried out with EPDS score and DAS-16 scale and PPQ and MIBS questionnaire.
Sample size justification The inclusion of 452 women will allow to detect at least a 5 points change in the proportion of postpartum depression during COVID pandemic period compared to the expected/usual proportion of 15% (15 vs. 20%) with 80% of power, considering two-sided alpha risk of 5% and 5% of dropout.
- Conditions
- Post Partum Depression
- Being tested
- psychological assessment
- Keywords
- COVID-19 - Sars-CoV2, quarantine Depression, Postpartum
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological assessmentBehavioural
psychological assessment at D10-12 and 6-8 weeks : Scheduled telephone interview using the assessment scales (EPDS, PPQ, MIBS, DAS-16) on D10-D12 and 6-8 weeks postpartum with a psychologist
| Study group | Role | What they receive |
|---|---|---|
| women in postpartum period | Experimental | Not described Receives: Behavioral: psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with postpartum depression defined by an EPDS score >12
assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic
Measured: Between week 6 and week 8
Proportion of patients with postpartum depression defined by an EPDS score >12
assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic
Measured: Between day 10 and day 12
Secondary outcomes (8)
Socio-demographic data
Measured: Between day 1 and day 5
Occurrence of a maternal or fetal pathology in a previous pregnancy
Measured: Between day 1 and day 5
Pregnant maternal pathology (hypertension, diabetes, threat of premature delivery)
Measured: Between day 1 and day 5
Presence of psycological maternal risk factor
as above, maternal psychological history as vulnerability factor included : history of perinatal loss, IMG, history of post partum depression.
Measured: Between day 1 and day 5
Dyadic adjustment scale 16 (DAS-16)
Measured: Between day 10 and day 12 and at between week 6 and week 8
Perinatal post traumatic stress disorder questionnaire (PPQ scale)
Measured: Between day 10 and day 12
Mother to infant bonding scale (MIBS) autoquestionnaire
Measured: Between day 10 and day 12 and at between week 6 and week 8
Measure Qualitative Interviews by Grounded theory
Participants will be asked open-ended questions about their post-partum experience in the context of COVID-19 epidemic lockdown. The interviews will be transcribed and tagged with codes which have been extracted from the data. As more data is collected codes can be regrouped into concepts and then categories. These categories are the basis of the "theory model" that emerge from the narrative of the patients.
The verbatim of the interview will be analyzed using NVIVO software which allows a grounded theory approach.
Using software package as Nvivo (Hutchison, 2010) with automatic analysis of the verbatim to extract codes and concepts provides a transparent account of the data and enhance study validity.
Verbatim are download in the software, that extract repeated lexical fields the categories from the mother's narrative.
As this is a qualitative study, there are no expected outcomes. Outcomes will be determined by the themes that arise from the post-partum interview process.
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start27 Apr 2020
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marie JOUANNIC, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366817
- Sponsor's protocol ID
- APHP200471
- Acronym
- COVMUM
- Status last verified
- Jun 2022
- First submitted
- 20 Apr 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Viaux-Savelon S, Maurice P, Rousseau A, Leclere C, Renout M, Berlingo L, Cohen D, Jouannic JM. Impact of COVID-19 lockdown on maternal psychological status, the couple's relationship and mother-child interaction: a prospective study. BMC Pregnancy Childbirth. 2022 Sep 26;22(1):732. doi: 10.1186/s12884-022-05063-6.
PubMed 36163044
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT04366817
- Acronym / sponsor ID
- COVMUM / APHP200471
- Conditions
- Post Partum Depression
- Keywords
- COVID-19 - Sars-CoV2, quarantine Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 29 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.
The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Sorbonne University of the Pitié-Salpêtrière, Trousseau and Tenon sites, from March 20, 2020 to no longer authorize visits during the stay of mothers following childbirth. This prohibition has also been extended to spouses. This measure was guided by a concern to protect both the patients, their newborn and the entire staff of the aftermath.
The period surrounding a birth is a period of strong emotional impact with an incidence of postpartum depression estimated at 15% in the general population (1). The separation of women from their spouses during this period could expose them to greater psychological vulnerability. In addition, when they return home, the patients will be isolated from their relatives due to the quarantine, which is an additional risk factor for postpartum depression. The teams of the three maternity units of AP-HP. Sorbonne University have organized themselves to be able to respond to situations of mental vulnerability during their stay with the intervention of maternity psychologists and psychiatrists and child psychiatrists as is done in the treatment usual charge. In addition, anticipating situations of greater vulnerability linked to the health crisis, the Maternity teams decided to set up a follow-up of patients after their return home through a telephone interview with psychologists or student psychologists in Master at D10 - D12 and 6-8 weeks postpartum in order to identify patients at increased risk of postpartum depression and to set up appropriate management if necessary for these patients.
We therefore propose through this project to describe the consequences of this separation from the spouse during the postpartum stay and then with the family after returning home within the context of quarantine by assessing the incidence of post-partum depression during this sanitary crisis. A telephone interview of all the patients will be proposed on D10 - D12 and at 6-8 weeks postpartum using specific questionnaire to calculate a score of depression. This early identification will allow the establishment of an adapted psychological follow-up.
Detailed description
The main objective of this study is to assess the emotional impact of the separation of women from their spouses following childbirth and their family isolation when returning home within the context of quarantine due to the COVID epidemic.
The secondary objectives are:
- To identify the factors of greatest vulnerability or resilience of the patients in the immediate postpartum period (6-8 weeks after delivery).
- To evaluate the impact of quarantine on the couples (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS) at D10-D12 postpartum and at 6-8 weeks postpartum.
- Recording of all interviews allowing a qualitative study of the verbatim by the use of N-Vivo software allowing the analysis of unstructured and qualitative data.
The primary endpoint will be the proportion of patients with postpartum depression defined by EPDS score >12 at D10-12 and 6-8 weeks postpartum. The EPDS relies on 10 specific items which allows the calculation of a depression score. A threshold > 12 is used in research to define the existence of depressive symptoms. For research, the score can be used as a continuous variable or in class with the threshold value 12.
The secondary end points will be:
- to study factors of greatest vulnerability or resilience of the patients will be studied:
- Socio-economic data
- maternal or fetal pathology during previous pregnancies
- associated pregnancy pathology
- Maternal psychologic history
- to describe the impact on the couple (DAS-16 scale), the experience of childbirth (PPQ scale), mother-child interactions (MIBS):
- Dyadic Adjustment scale 16 (DAS-16). Revised scale was developed to assess dyadic adjustment in marriage.
- Perinatal Posttraumatic Stress Disorder Questionnaire (PPQ). This self-questionnaire makes it possible to assess the post-traumatic reactions of parents faced with the birth of a child presenting a high perinatal risk.
- Mother-to-Infant Bonding Scale (MIBS): Auto questionnaire, initially developed with a view to researching disturbances in maternal feelings towards the newborn. The scores range from 0 to 24, a high score being in favor of a mother-child bond disorder.
- Automated psycho-linguistic analysis of the interviews using the N Vivo software. This software allows an automated study of the verbatim allowing a qualitative analysis of prosody and to identify emotional profiles and thus to identify situations of anxiety, stress and depression.
The study population will consist of patients with delivery of a child and:
- Singleton pregnancy
- Alive child without hospitalization of the child in NICU
- Patient speaking and understanding French
- Major patient
Duration of inclusion will be 2 months The Inclusion visit will take place during hospitalization in post-partum units, signed consent informed will be collected by a qualified person (medical doctor or midwife) before inclusion. Each week, these forms will be sent to the study psychologist referent in each of the 3 Maternity units.
Research follow-up visits:
Scheduled telephone interview using the assessment scales described above on D10-D12 and 6-8 weeks postpartum with a psychologist or an M2 psychology student under the responsibility of a maternity psychologist. A reminder system is provided by sending an SMS / email 48 hours before the scheduled call. In the event of a missed call, a re-call is scheduled on the same day or the next day (the SMS / email sent to patients indicates this reminder mode in the event of unavailability during the first call).
During this call, a semi-structured interview is carried out with EPDS score, DAS-16 scale, PPQ and MIBS questionnaire, and a recording for analysis of unstructured and qualitative data.
When EPDS score> 12: proposal for psychological follow-up in accordance with current standard of care in the event of postpartum depression.
For scores <12, the possibility of a further interview with a psychologist, apart from the study, is formulated.
Telephone interview at 6-8 weeks with psychologist including, as previously described, a semi-structured interview with EPDS score, DAS-16 scale and MIBS questionnaire and a recording for analysis of unstructured and qualitative data When EPDS score> 12: proposal for psychological follow-up in accordance with current standard of care in the event of postpartum depression.
For scores <12, the possibility of a further interview with a psychologist is formulated.
The patients were informed of the recording of the calls. In case of refusal, the calls are not recorded and only the semi-structured interview is carried out with EPDS score and DAS-16 scale and PPQ and MIBS questionnaire.
Sample size justification The inclusion of 452 women will allow to detect at least a 5 points change in the proportion of postpartum depression during COVID pandemic period compared to the expected/usual proportion of 15% (15 vs. 20%) with 80% of power, considering two-sided alpha risk of 5% and 5% of dropout.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women in postpartum period | Experimental | Behavioral: psychological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -- Single pregnancy
- Birth of a child living without hospitalisation of the child in Neonatology (outside the accommodation of the newborn in Neonatology for maternal reasons)
- Patient speaks and understands French
- Patient affiliated to social security
- Major patient
Key exclusion criteria (1 listed)
- Protected patient or patient unable to give consent
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 |
|---|---|---|
| psychological assessmentpsychological assessment at D10-12 and 6-8 weeks : Scheduled telephone interview using the assessment scales (EPDS, PPQ, MIBS, DAS-16) on D10-D12 and 6-8 weeks postpartum with a psychologist | Behavioural | women in postpartum period |
Primary outcome
Proportion of patients with postpartum depression defined by an EPDS score >12
Time frame: Between week 6 and week 8
assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic
Proportion of patients with postpartum depression defined by an EPDS score >12
Time frame: Between day 10 and day 12
assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic
8 secondary outcomes
Socio-demographic data
Time frame: Between day 1 and day 5
Occurrence of a maternal or fetal pathology in a previous pregnancy
Time frame: Between day 1 and day 5
Pregnant maternal pathology (hypertension, diabetes, threat of premature delivery)
Time frame: Between day 1 and day 5
Presence of psycological maternal risk factor
Time frame: Between day 1 and day 5
Dyadic adjustment scale 16 (DAS-16)
Time frame: Between day 10 and day 12 and at between week 6 and week 8
Perinatal post traumatic stress disorder questionnaire (PPQ scale)
Time frame: Between day 10 and day 12
Mother to infant bonding scale (MIBS) autoquestionnaire
Time frame: Between day 10 and day 12 and at between week 6 and week 8
Measure Qualitative Interviews by Grounded theory
Time frame: Week 14
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 30 Jun 2022.
- Derived from this study: PubMed 36163044Viaux-Savelon S, Maurice P, Rousseau A, Leclere C, Renout M, Berlingo L, Cohen D, Jouannic JM. Impact of COVID-19 lockdown on maternal psychological status, the couple's relationship and mother-child interaction: a prospective study. BMC Pregnancy Childbirth. 2022 Sep 26;22(1):732. doi: 10.1186/s12884-022-05063-6.
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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.
Jean Marie JOUANNIC, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological assessment in people with Post Partum Depression, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 1 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 30 Jun 2022. 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?
Proportion of patients with postpartum depression defined by an EPDS score >12 (time frame: Between week 6 and week 8). The study lists 2 primary outcomes in all. 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 NCT04366817, 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 30 Jun 2022.