Covid-19NCT04432948
Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.
An observational study of Covid-19 and Maternal Psychological Distress, run by General and Maternity Hospital of Athens Elena Venizelou at 1 site in Greece.
Trial summary
The aim of this study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Covid-19, Maternal Psychological Distress, Anesthesia
- What is being tested?
- PHQ-9 Depression Scale, GAD-7 General anxiety disorder scale and 38-questions questionnaire
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 15 May 2020to Dec 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: All women in labour that present into the maternity hospital from June-August 2020, during the Covid-19 pandemic
Who may be able to join
- All pregnant women over the age of 18 that present in labour (vaginal delivery or caesarean section)
Who cannot join
- psychiatric disorders
- drug abuse
- not eligible to read and write in Greek
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
"Elena Venizelou" General and Maternity Hospital of Athens
Athens, Attica, 11521
Georgia Micha, Dr
About this study
The aim of this study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.
- Conditions
- Covid-19, Maternal Psychological Distress, Anesthesia
- Being tested
- PHQ-9 Depression Scale, GAD-7 General anxiety disorder scale, 38-questions questionnaire
- Keywords
- Covid-19, Psychological Distress, Maternal, Anaesthesia
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHQ-9 Depression ScaleOther
It involves a 9-question scale that detects depression
GAD-7 General anxiety disorder scaleOther
It involves a 7-question scale that detects general anxiety disorder
38-questions questionnaireOther
It involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice
| Study group | Role | What they receive |
|---|---|---|
| Maternal Group | Pregnant women administered into a maternity public hospital in labour (vaginal delivery, caesarean section) Receives: Other: PHQ-9 Depression Scale; Other: GAD-7 General anxiety disorder scale; Other: 38-questions questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Covid-19 pandemic and maternal psychological distress
Association between Covid-19 pandemic and maternal psychological distress assessed by 2 scales and one questionnaire
Measured: Pre-labour assessment
Secondary outcomes (1)
Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice
Association between Covid-19 pandemic and anaesthetic practice assessed by a 38 questions questionnaire
Measured: Pre-labour assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 May 2020
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
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 Covid-19Studies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General and Maternity Hospital of Athens Elena Venizelou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEORGIA MICHA, General and Maternity Hospital of Athens Elena Venizelou
- Investigators
- Georgia Micha, Dr, Principal investigator, Elena Venizelou General and Maternity Hospital of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432948
- Sponsor's protocol ID
- Maternal Covid 19
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.
PubMed 32374420
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Psychological Implications of Covid-19 Pandemic and Possible Effect on Anaesthetic Management.
- ClinicalTrials.gov ID
- NCT04432948
- Acronym / sponsor ID
- Maternal Covid 19
- Conditions
- Covid-19, Maternal Psychological Distress, Anesthesia
- Keywords
- Covid-19, Psychological Distress, Maternal, Anaesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- General and Maternity Hospital of Athens Elena VenizelouUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 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 study is to assess the maternal psychological implication of the novel coronavirus COvid-19 pandemic. At the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maternal Group | – | Other: PHQ-9 Depression Scale, Other: GAD-7 General anxiety disorder scale, Other: 38-questions questionnairePregnant women administered into a maternity public hospital in labour (vaginal delivery, caesarean section) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women in labour that present into the maternity hospital from June-August 2020, during the Covid-19 pandemic
Key inclusion criteria (1 listed)
- All pregnant women over the age of 18 that present in labour (vaginal delivery or caesarean section)
Key exclusion criteria (3 listed)
- psychiatric disorders
- drug abuse
- not eligible to read and write in Greek
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 Depression ScaleIt involves a 9-question scale that detects depression | Other | Maternal Group |
| GAD-7 General anxiety disorder scaleIt involves a 7-question scale that detects general anxiety disorder | Other | Maternal Group |
| 38-questions questionnaireIt involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice | Other | Maternal Group |
Primary outcome
Association between Covid-19 pandemic and maternal psychological distress
Time frame: Pre-labour assessment
Association between Covid-19 pandemic and maternal psychological distress assessed by 2 scales and one questionnaire
1 secondary outcome
Association between Covid-19 pandemic, maternal psychological distress and anaesthetic practice
Time frame: Pre-labour assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 32374420Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.
- Individual participant dataSharing planned: Undecided
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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, Dr principal investigator
Elena Venizelou General and Maternity Hospital of Athens, Greece
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 Covid-19 and Maternal Psychological Distress, run by General and Maternity Hospital of Athens Elena Venizelou at 1 site 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 3 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 16 Jun 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgia Micha, Dr (+306974828254, mgeo3@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Covid-19 pandemic and maternal psychological distress (time frame: Pre-labour assessment). 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 NCT04432948, 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 16 Jun 2020.