- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629638
Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women
December 19, 2020 updated by: Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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İ̇stanbul
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Istanbul, İ̇stanbul, Turkey, 34000
- Pinar Yalcin Bahat
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- covid -19 positive and negative pregnant women
- have no psychiatric illness
- not using antidepressants or antipsychotic drugs
Exclusion Criteria:
- women with psychiatric illness
- using antidepressants or antipsychotic drugs
- not pregnant
- adolescent pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
|
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.
|
The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
November 15, 2020
Study Completion (Actual)
November 20, 2020
Study Registration Dates
First Submitted
November 12, 2020
First Submitted That Met QC Criteria
November 13, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
December 22, 2020
Last Update Submitted That Met QC Criteria
December 19, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Depression
- Depressive Disorder
- COVID-19
- Anxiety Disorders
Other Study ID Numbers
- maternalattachmentcovid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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