Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic

NCT04558749 | Completed

• 1 other identifier: ADCOVID
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

  one hour

Study Arms (1)

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; Other: Edinburgh Postnatal Depression Scale (EDPS)

Interventions

State-trait anxiety inventory scale OTHER

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.

Study group

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• All pregnant women presented to the Antenatal care clinic, will be included in the study irrespective of the gestational age of the pregnancy

You may not qualify if:

• Women previously diagnosed with any psychiatric disorder.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)