Covid19NCT04558749
Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
Trial summary
Pregnancy and early parenthood are life changing periods characterized by intense emotions and a high vulnerability to emotional problems. Overall 10 - 20 % of pregnant women and women in early postpartum period suffer from mental health problems. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- State-trait anxiety inventory scale and Edinburgh Postnatal Depression Scale (EDPS)
- How many people
- 238 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 28 Feb 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population comprised women that will attend their routine visit to the antenatal clinic. The study population will be recruited by using simple random sampling method after verbal consent will be obtained. Resident in the Department of Obstetrics and Gynaecology who will be trained to administer the questionnaire will interview women. Facemasks will be provided to the study population during the process of data collection.
Who may be able to join
- All pregnant women presented to the Antenatal care clinic, will be included in the study irrespective of the gestational age of the pregnancy
Who cannot join
- Women previously diagnosed with any psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic
Pregnancy and early parenthood are life changing periods characterized by intense emotions and a high vulnerability to emotional problems. Overall 10 - 20 % of pregnant women and women in early postpartum period suffer from mental health problems.
In the first months of 2020 , pregnant and breastfeeding women have also needed to face the COVID19 pandemic including the exceptional quarantine measures that have disturbed private and professional life . In addition to the fear of infection , these measures might have negatively impacted the emotional wellbeing of women . As depressive symptoms and anxiety in the pre and peripartum period have been associated with adverse maternal , neonatal and infant outcomes , the psychological impact of COVID19 , and its associated quarantine measures , on pregnant women and new mothers is cause for concern
- Conditions
- Covid19
- Being tested
- State-trait anxiety inventory scale, Edinburgh Postnatal Depression Scale (EDPS)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-trait anxiety inventory scaleOther
This scale is composed of two parts, part one measures anxiety traits and part two measures anxiety state. Each part comprises 20 statements. This scale is a (4) point scale, with a score ranging a minimum of 20 grades to a maximum of 80 grades.
Edinburgh Postnatal Depression Scale (EDPS)Other
The EPDS is a self-report measure that focuses on the cognitive symptoms of depression. It excludes somatic items that might generate false positives both during pregnancy and after childbirth.7 The EPDS consists of 10 items, each scored 0-3 points, with a potential scale score of 0-30.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study population comprised women that will attend their routine visit to the antenatal clinic. The study population will be recruited by using simple random sampling method after verbal consent will be obtained. Resident in the Department of Obstetrics and Gynaecology who will be trained to administer the questionnaire will interview women. Face masks will be provided to the study population during the process of data collection. Receives: Other: State-trait anxiety inventory scale; Other: Edinburgh Postnatal Depression Scale (EDPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean scores anxiety and depression among pregnant women during COVID-19 pandemic
This scale is composed of two parts, part one measures anxiety traits and part two measures anxiety state. Each part comprises 20 statements. This scale is a (4) point scale, with a score ranging a minimum of 20 grades to a maximum of 80 grades.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558749
- Sponsor's protocol ID
- ADCOVID
- Status last verified
- May 2024
- First submitted
- 18 Sep 2020
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04558749
- Acronym / sponsor ID
- ADCOVID
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Sep 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.
Pregnancy and early parenthood are life changing periods characterized by intense emotions and a high vulnerability to emotional problems. Overall 10 - 20 % of pregnant women and women in early postpartum period suffer from mental health problems.
In the first months of 2020 , pregnant and breastfeeding women have also needed to face the COVID19 pandemic including the exceptional quarantine measures that have disturbed private and professional life . In addition to the fear of infection , these measures might have negatively impacted the emotional wellbeing of women . As depressive symptoms and anxiety in the pre and peripartum period have been associated with adverse maternal , neonatal and infant outcomes , the psychological impact of COVID19 , and its associated quarantine measures , on pregnant women and new mothers is cause for concern
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: State-trait anxiety inventory scale, Other: Edinburgh Postnatal Depression Scale (EDPS)The study population comprised women that will attend their routine visit to the antenatal clinic. The study population will be recruited by using simple random sampling method after verbal consent will be obtained. Resident in the Department of Obstetrics and Gynaecology who will be trained to administer the questionnaire will interview women. Face masks will be provided to the study population during the process of data collection. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprised women that will attend their routine visit to the antenatal clinic. The study population will be recruited by using simple random sampling method after verbal consent will be obtained. Resident in the Department of Obstetrics and Gynaecology who will be trained to administer the questionnaire will interview women. Facemasks will be provided to the study population during the process of data collection.
Key inclusion criteria (1 listed)
- All pregnant women presented to the Antenatal care clinic, will be included in the study irrespective of the gestational age of the pregnancy
Key exclusion criteria (1 listed)
- Women previously diagnosed with any psychiatric disorder.
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 |
|---|---|---|
| State-trait anxiety inventory scaleThis scale is composed of two parts, part one measures anxiety traits and part two measures anxiety state. Each part comprises 20 statements. This scale is a (4) point scale, with a score ranging a minimum of 20 grades to a maximum of 80 grades. | Other | Study group |
| Edinburgh Postnatal Depression Scale (EDPS)The EPDS is a self-report measure that focuses on the cognitive symptoms of depression. It excludes somatic items that might generate false positives both during pregnancy and after childbirth.7 The EPDS consists of 10 items, each scored 0-3 points, with a potential scale score of 0-30. | Other | Study group |
Primary outcome
The mean scores anxiety and depression among pregnant women during COVID-19 pandemic
Time frame: one hour
This scale is composed of two parts, part one measures anxiety traits and part two measures anxiety state. Each part comprises 20 statements. This scale is a (4) point scale, with a score ranging a minimum of 20 grades to a maximum of 80 grades.
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 3 Jun 2024.
- Individual participant dataSharing planned: No
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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.
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 Covid19, run by Assiut University at 1 site in Egypt.
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 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 3 Jun 2024. 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 Egypt. 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?
The mean scores anxiety and depression among pregnant women during COVID-19 pandemic (time frame: one hour). 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 3 Jun 2024.