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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04609501
Collaborator
(none)
440
Enrollment
1
Location
49
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    440 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship in the Shadow of a Socioeconomic Crisis
    Actual Study Start Date :
    Jun 1, 2020
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of COVID-19 during pregnancy [1 year after delivery]

      Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale

    2. The relations between fear of COVID-19 and postnatal depression symptoms. [1 year after delivery]

      Postnatal depression was evaluated using the EPDS.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center Hadera Israel 38100

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center

    Investigators

    • Principal Investigator: Rinat Gabbay-Benziv, MD, Hillel Yaffe Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT04609501
    Other Study ID Numbers:
    • 0082-20-HYMC
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 23, 2022