- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558749
Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt
- Assiut Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All pregnant women presented to the Antenatal care clinic, will be included in the study irrespective of the gestational age of the pregnancy
Exclusion Criteria:
Women previously diagnosed with any psychiatric disorder.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean scores anxiety and depression among pregnant women during COVID-19 pandemic
Time Frame: one hour
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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.
|
one hour
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADCOVID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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