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Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04910958
Collaborator
(none)
1,000
Enrollment
1
Location
24.8
Anticipated Duration (Months)
40.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There is no research in the literature that has compared the rates and behavior of miscarriage during the time of the COVID-19 pandemic to before the time of the pandemic. As described in the literature, there is an established connection between COVID-19 and stress, anxiety, and depression. There is also an established connection between stress, anxiety, and depression and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19 pandemic on miscarriages.

    In this study, The investigators will analyze the number of early missed abortions and number of termination of pregnancies in the first trimester before and during the COVID-19 pandemic. The investigators will also analyze the time interval between diagnosis of missed abortion and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The investigators will be comparing the reasons for termination of pregnancy during this time, as well as analyzing age, religion, and demographic variables during the COVID-19 pandemic compared to years prior.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
    Actual Study Start Date :
    Jan 6, 2021
    Anticipated Primary Completion Date :
    Jan 31, 2023
    Anticipated Study Completion Date :
    Jan 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of early missed abortions [Two years]

      Number of early missed abortions in the first trimester in COVID19 time compared to years prior

    2. Number of termination of pregnancies [Two years]

      Number of termination of pregnancies in the first trimester in COVID19 time compared to years prior

    Secondary Outcome Measures

    1. Time between discovery and attendance [1 year]

      Time between discovery and attendance in missed abortions during COVID19 time compared to years prior

    2. Comparison of reasons for termination [1 year]

      Comparison of reasons for termination of pregnancy during COVID19 time compared to years prior

    3. Comparison of Age/Religion/Demographic variables [1 year]

      Comparison of Age/Religion/Demographic variables of termination of pregnancy during COVID19 time compared to years prior

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)
    Exclusion Criteria:

    • Incomplete and complete abortions

    • Gestational age >13 weeks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hillel Yaffe Medical Center Hadera Israel

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center

    Investigators

    • Principal Investigator: Omer Mor, MD, omer.moore@gmail.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT04910958
    Other Study ID Numbers:
    • 0199-20-HYMC
    First Posted:
    Jun 2, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Abortion, Spontaneous

    Study Results

    No Results Posted as of Jun 28, 2022