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NCT04609501 Clinical Trial

Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship

Covid19 Clinical Trial

Official title:
Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship in the Shadow of a Socioeconomic Crisis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04609501
Other study ID # 0082-20-HYMC
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 30, 2024

Study information
Verified date June 2022
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females. In this study, we aimed to evaluate the relations between the fear of COVID-19 and postnatal depression symptoms.

Description:

This is a multicenter prospective cohort study of childbearing women during COVID-19. Participants completed a comprehensive online questionnaire including demographic, socioeconomic, obstetric, and postnatal mental-health questionnaires. Data were verified with each center's perinatal database and information regarding physiological stress during pregnancy/birth was also collected. Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale and postnatal depression was evaluated using the EPDS. Pre-existing maternal disability was defined as prior physiological or psychological chronic health condition.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 440
Est. completion date June 30, 2024
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - women who delivered during the Covid-19 pandemic at the site, since 01-March-2020 Exclusion Criteria: - women age 18 and below - Gestational age under 34 weeks - Intra Uterine Fetal Demise - Ante-partum Fetal Demise - Maternal post partum death

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of COVID-19 during pregnancy Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale 1 year after delivery
Primary The relations between fear of COVID-19 and postnatal depression symptoms. Postnatal depression was evaluated using the EPDS. 1 year after delivery
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