Postpartum DepressionNCT04437342
Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia
An observational study of Postpartum Depression and Psychological Stress, run by General and Maternity Hospital of Athens Elena Venizelou at 6 sites in Greece.
Trial summary
The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Psychological Stress, Maternal Distress
- What is being tested?
- PHQ-9 (Patient Health Questionnaire) Depression Scale, GAD-7 (General Anxiety Disorder) scale and 38 questions questionnaire
- How many people
- 330 participants
- Where
- 6 sitesGreece
- Study dates
- 30 Jun 2020to 27 Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women admitted to the hospital for vaginal delivery or caesarean section
Who may be able to join
- All pregnant women over the age of 18 that present for labour (vaginal delivery or caesarean section)
Who cannot join
- Not eligible in writing and reading in Greek
- Drug abuse
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
"Elena Venizelou" General and Maternity Hospital of Athens
Athens, Attica, 11521
Aretaieio University Hospital
Athens, Attica
Alexandra Genaral Hospital Athens
Athens
University of Ioannina Health Science
Ioannina
University of Ioannina, Medical School
Ioannina
University of Thessaly Medical School
Larissa
About this study
The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables
- Being tested
- PHQ-9 (Patient Health Questionnaire) Depression Scale, GAD-7 (General Anxiety Disorder) scale, 38 questions questionnaire, EPDS (Edinburgh Postnatal Depression Scale)
- Keywords
- postpartum depression, Covid-19 pandemic, anaesthesia
- Medical subject headings
- Depression, Postpartum, Stress, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHQ-9 (Patient Health Questionnaire) Depression ScaleOther
9 question questionnaire for assessment of depression
GAD-7 (General Anxiety Disorder) scaleOther
7 question questionnaire for assessment of General Anxiety Disorder
38 questions questionnaireOther
38 questions questionnaire
EPDS (Edinburgh Postnatal Depression Scale)Other
10 questions scale for detection of postpartum depression
| Study group | Role | What they receive |
|---|---|---|
| Maternal Group | Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression. Receives: Other: PHQ-9 (Patient Health Questionnaire) Depression Scale; Other: GAD-7 (General Anxiety Disorder) scale; Other: 38 questions questionnaire; Other: EPDS (Edinburgh Postnatal Depression Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)
Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)
Measured: 40 days postpartum
Secondary outcomes (3)
Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
Measured: 10 minutes postpartum
Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)
Measured: 2 minutes prior to discharge from the Postanaesthesia care unit
Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)
Measured: 2 minutes after admission to the Postanaesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Aug 2020
- Study completion27 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- General and Maternity Hospital of Athens Elena Venizelou
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece, University of Ioannina, Larissa University Hospital
- Responsible party
- Principal investigator, GEORGIA MICHA, General and Maternity Hospital of Athens Elena Venizelou
- Investigators
- Georgia Micha, PhD, Principal investigator, Elena Venizelou General and Maternity Hospital of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437342
- Sponsor's protocol ID
- Covid-19 Postpartum depression
- Status last verified
- Oct 2020
- First submitted
- 15 Jun 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data, study protocol and statistical analysis plan will be available to the scientific community after publication. The corresponding author is responsible for reviewing these requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia
- ClinicalTrials.gov ID
- NCT04437342
- Acronym / sponsor ID
- Covid-19 Postpartum depression
- Keywords
- postpartum depression, Covid-19 pandemic, anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- General and Maternity Hospital of Athens Elena VenizelouUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece, University of Ioannina, Larissa University Hospital
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 18 Jun 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 aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maternal Group | – | Other: PHQ-9 (Patient Health Questionnaire) Depression Scale, Other: GAD-7 (General Anxiety Disorder) scale, Other: 38 questions questionnaire, Other: EPDS (Edinburgh Postnatal Depression Scale)Pregnant women in labour (vaginal delivery or caesarean section) that are admitted to the hospital. Pre-labour 3 different questionnaires are administered to evaluate depression, general anxiety disorder and the association to the covid-19 pandemic. 40 days post delivery via telephone contact 2 questionnaires are administered, one in order to assess the postpartum disorder the other to assess depression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women admitted to the hospital for vaginal delivery or caesarean section
Key inclusion criteria (1 listed)
- All pregnant women over the age of 18 that present for labour (vaginal delivery or caesarean section)
Key exclusion criteria (2 listed)
- Not eligible in writing and reading in Greek
- Drug abuse
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 |
|---|---|---|
| PHQ-9 (Patient Health Questionnaire) Depression Scale9 question questionnaire for assessment of depression | Other | Maternal Group |
| GAD-7 (General Anxiety Disorder) scale7 question questionnaire for assessment of General Anxiety Disorder | Other | Maternal Group |
| 38 questions questionnaire38 questions questionnaire | Other | Maternal Group |
| EPDS (Edinburgh Postnatal Depression Scale)10 questions scale for detection of postpartum depression | Other | Maternal Group |
Primary outcome
Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)
Time frame: 40 days postpartum
Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)
3 secondary outcomes
Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
Time frame: 10 minutes postpartum
Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
Time frame: 2 minutes prior to discharge from the Postanaesthesia care unit
Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
Time frame: 2 minutes after admission to the Postanaesthesia care unit
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 6 Jan 2021.
- Individual participant dataSharing planned: Yes. Research data, study protocol and statistical analysis plan will be available to the scientific community after publication. The corresponding author is responsible for reviewing these requests.
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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.
Georgia Micha, PhD principal investigator
Elena Venizelou General and Maternity Hospital of Athens, Greece
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression and Psychological Stress, run by General and Maternity Hospital of Athens Elena Venizelou at 6 sites in Greece.
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 1 inclusion and 2 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 6 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 6 sites in Greece. 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?
Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale) (time frame: 40 days 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 6 Jan 2021.