Covid19NCT04629638
Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women
An observational study of Covid19 and Depression, Anxiety, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19, Depression, Anxiety, Pregnancy Related
- What is being tested?
- Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 20 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Maternal attachment, edinburgh depression score and postpartum anxiety scale scores of 250 covid-19 positive pregnant women between the ages of 18-45 and 250 covid-negative pregnant women are compared.
Who may be able to join
- covid -19 positive and negative pregnant women
- have no psychiatric illness
- not using antidepressants or antipsychotic drugs
Who cannot join
- women with psychiatric illness
- using antidepressants or antipsychotic drugs
- not pregnant
- adolescent pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth.
Read the detailed description
Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale are evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
- Conditions
- Covid19, Depression, Anxiety, Pregnancy Related
- Being tested
- Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores
- Medical subject headings
- COVID-19, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scoresOther
The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
| Study group | Role | What they receive |
|---|---|---|
| covid -19 positive pregnant women | Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in 250 covid-positive pregnant women in the 3rd month after birth. Receives: Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores | |
| covid -19 negative pregnant women | Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in 250 covid-negative pregnant women in the 3rd month after birth. Receives: Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal attachment in SARS- cov2 positive and negative pregnant women
Maternal attachment scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. High scores from the scale indicate high maternal attachment.
Measured: 3 months
Edinburgh depression scores in in SARS- cov2 positive and negative pregnant women
Edinburgh depression scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. All questions are scored between 0 and 3 and the highest possible score on the scale is 30. and shows advanced depression.
Measured: 3 months
Postpartum anxiety scale scores in in SARS- cov2 positive and negative pregnant women
Postpartum anxiety scale scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. It can be said that the postpartum anxiety levels of those who score 73 and below on the scale are low, those who score between 74 and 100 are medium, and those who score 101 and above are high.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Aug 2020
- Primary completion15 Nov 2020
- Study completion20 Nov 2020
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629638
- Sponsor's protocol ID
- maternalattachmentcovid
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2020
- Last updated
- 22 Dec 2020
- 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women
- ClinicalTrials.gov ID
- NCT04629638
- Acronym / sponsor ID
- maternalattachmentcovid
- Conditions
- Covid19, Depression, Anxiety, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 16 Nov 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.
Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth.
Detailed description
Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale are evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covid -19 positive pregnant women | – | Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scoresMaternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in 250 covid-positive pregnant women in the 3rd month after birth. |
| covid -19 negative pregnant women | – | Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scoresMaternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in 250 covid-negative pregnant women in the 3rd month after birth. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Maternal attachment, edinburgh depression score and postpartum anxiety scale scores of 250 covid-19 positive pregnant women between the ages of 18-45 and 250 covid-negative pregnant women are compared.
Key inclusion criteria (3 listed)
- covid -19 positive and negative pregnant women
- have no psychiatric illness
- not using antidepressants or antipsychotic drugs
Key exclusion criteria (4 listed)
- women with psychiatric illness
- using antidepressants or antipsychotic drugs
- not pregnant
- adolescent pregnancy
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 |
|---|---|---|
| Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scoresThe results will be compared with the results of covid-negative pregnant women who gave birth in the same period. | Other | covid -19 negative pregnant women, covid -19 positive pregnant women |
Primary outcome
Maternal attachment in SARS- cov2 positive and negative pregnant women
Time frame: 3 months
Maternal attachment scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. High scores from the scale indicate high maternal attachment.
Edinburgh depression scores in in SARS- cov2 positive and negative pregnant women
Time frame: 3 months
Edinburgh depression scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. All questions are scored between 0 and 3 and the highest possible score on the scale is 30. and shows advanced depression.
Postpartum anxiety scale scores in in SARS- cov2 positive and negative pregnant women
Time frame: 3 months
Postpartum anxiety scale scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. It can be said that the postpartum anxiety levels of those who score 73 and below on the scale are low, those who score between 74 and 100 are medium, and those who score 101 and above are high.
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 22 Dec 2020.
- 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 and Depression, Anxiety, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 22 Dec 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 Turkey (Türkiye). 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?
Maternal attachment in SARS- cov2 positive and negative pregnant women (time frame: 3 months). The study lists 3 primary outcomes in all. 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 22 Dec 2020.