Postnatal DepressionDEPRECOVIDNCT04368208
Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression
An observational study of Postnatal Depression, run by Poitiers University Hospital at 1 site in France.
Trial summary
Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery
- How many people
- 501 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2020to 27 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 to 50 years
- Women only
- Adult
Study population: Women who deliver of a single baby, at term and in cephalic presentation whatever is the modalities of delivery (instrumental, cesarean, spontaneous delivery) will be included after their delivery. Premature and non cephalic birth will be excluded because they are specific deliveries that may be assoictaed with a specific maternal anxietey. Women with psychiatric disorders are excluded since we investigated the occurrence of postnatal depression which is a psychiatric disorder. Women without any internet access are excluded because women will have to fill online questionnaires. Finally women will be informed, as well as their doctors, in case of postnatal depression with an advice of planning a medical consultation.
Who may be able to join
- women older than 18 years
- women who deliver of a singleton, term neonate in cephalic presentation
Who cannot join
- women younger than 18 years
- women who deliver of a baby in non cephalic presentation
- women with pre term Birth
- women without any internet access
- women with psychiatric disorders
- women who do not understand french language
- women who refuse to be aware of the results of the postnatal depression screening and who refuse that her doctor be ware of the results
Trial locations and contacts
1 site in 1 country.
About this study
Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health.
The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression.
It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.
- Conditions
- Postnatal Depression
- Being tested
- Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery
- Keywords
- childbirth, covid 19, satisfaction
- Medical subject headings
- Depression, Postpartum, COVID-19, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after deliveryOther
Also called Assessment of satisfaction about childbirth using the WOMBLSQ4 questionnaire within the week after delivery, Retrospective assessment of prenatal anxiety within the week after the delivery, Assessment of pelvic floor disorders using the PFDI questionnaire between 4 and 6 weeks after delivery, Assessment of self rated health for the woman and the child using the WHO question about self rated health between 4 and 6 weeks after delivery
The Edinburgh questionnaire is a self questionnaire validated for postnatal depression between 4 and 6 weeks postnatal
What is being measured
The primary outcome is the main question the study is designed to answer.
Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia
proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum
Measured: 4-6 weeks postpartum
Secondary outcomes (2)
Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia
Existence of an association with postnatal depression and these factors: socio demographic women's characteristics, modalities of pregnancy management, satisfaction and experience about delivery, postnatal pelvic floor disorders, self rated health for the woman and the child, modalities of delivery, prenatal anxiety
Measured: 4-6 weeks postpartum
Describe the experience and the satisfaction about delivery during the covid 19 pandemia
Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfaction
Measured: within the week after delivery
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 start29 Apr 2020
- Primary completion21 Oct 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368208
- Sponsor's protocol ID
- 2020-A01065-34
- Acronym
- DEPRECOVID
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression
- ClinicalTrials.gov ID
- NCT04368208
- Acronym / sponsor ID
- DEPRECOVID / 2020-A01065-34
- Conditions
- Postnatal Depression
- Keywords
- childbirth, covid 19, satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 27 Nov 2020 (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.
Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health.
The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression.
It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women who deliver of a single baby, at term and in cephalic presentation whatever is the modalities of delivery (instrumental, cesarean, spontaneous delivery) will be included after their delivery. Premature and non cephalic birth will be excluded because they are specific deliveries that may be assoictaed with a specific maternal anxietey. Women with psychiatric disorders are excluded since we investigated the occurrence of postnatal depression which is a psychiatric disorder. Women without any internet access are excluded because women will have to fill online questionnaires. Finally women will be informed, as well as their doctors, in case of postnatal depression with an advice of planning a medical consultation.
Key inclusion criteria (2 listed)
- women older than 18 years
- women who deliver of a singleton, term neonate in cephalic presentation
Key exclusion criteria (7 listed)
- women younger than 18 years
- women who deliver of a baby in non cephalic presentation
- women with pre term Birth
- women without any internet access
- women with psychiatric disorders
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 |
|---|---|---|
| Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after deliveryAlso: Assessment of satisfaction about childbirth using the WOMBLSQ4 questionnaire within the week after delivery, Retrospective assessment of prenatal anxiety within the week after the delivery, Assessment of pelvic floor disorders using the PFDI questionnaire between 4 and 6 weeks after delivery, Assessment of self rated health for the woman and the child using the WHO question about self rated health between 4 and 6 weeks after deliveryThe Edinburgh questionnaire is a self questionnaire validated for postnatal depression between 4 and 6 weeks postnatal | Other | – |
Primary outcome
Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia
Time frame: 4-6 weeks postpartum
proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum
2 secondary outcomes
Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia
Time frame: 4-6 weeks postpartum
Describe the experience and the satisfaction about delivery during the covid 19 pandemia
Time frame: within the week after delivery
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 26 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Postnatal Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Depression, run by Poitiers University Hospital 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 2 inclusion and 7 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 26 Jan 2021. 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?
Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia (time frame: 4-6 weeks postpartum). 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 26 Jan 2021.