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Completed

NCT Number: NCT04558749

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Assiut Faculty of Medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2020
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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