Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT04558749

Collaborator

(none)

200

Enrollment

Location

19.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: State-trait anxiety inventory scale Other: Edinburgh Postnatal Depression Scale (EDPS)

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Assessment of Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Mar 31, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: State-trait anxiety inventory scale 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. Other: 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.

Arm

Intervention/Treatment

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.

Other: State-trait anxiety inventory scale

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

The mean scores anxiety and depression among pregnant women during COVID-19 pandemic [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04558749

Other Study ID Numbers:

ADCOVID

First Posted:

Sep 22, 2020

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 25, 2022