Covid 19 Vaccine Acceptance in Egyptian Pregnant Women

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05258760
Collaborator
(none)
1,100
3.1

Study Details

Study Description

Brief Summary

To determine vaccine acceptance and hesitancy attitudes toward coronavirus disease 2019 (COVID-19) vaccines in Egyptian pregnant women.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Although 2 years passed since the Covid 19 pandemic started, no specific treatment against the disease is available. According to WHO, more than two million deaths have been recorded worldwide . Therefore, it is important to avoid infection. In the absence of an effective treatment for coronavirus disease 2019 (COVID-19) non-pharmaceutical interventions are the only available methods of disease control. Social distancing, face masks, and personal hygiene are the most effective precautions, but maintaining these actions is not practicable in the long term. As a result, vaccination becomes the most effective eradication method. (1,2) Research into development of a vaccine for SARS-CoV-2 was undertaken immediately after the disease was identified.(3) The success of a vaccine depends not only on its efficacy, but also its acceptance.

    However, vaccine hesitancy has become an important threat to global health, which was pointed out by WHO in 2019.(4) Several key factors behind vaccine hesitancy include fear or mistrust of the vaccine, underestimation of the value of the vaccine, and lack of access to the vaccine.(5) Pregnant women are at increased risk of severe disease, ICU admission, and ventilation when compared with non-pregnant patients of the same age.(6-8) Therefore, pregnant women are classified as a high-risk population for COVID-19 infection.(9) Regarding this information, pregnant women have not been included in any COVID-19 vaccine clinical trials to date.(10) Even so, public health authorities, including the ACOG and the SMFM recommend that COVID-19 vaccines should be available for pregnant women if they prefer to be vaccinated.(11,12)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Covid Vaccine Acceptance Among Egyptian Pregnant Women
    Anticipated Study Start Date :
    Feb 26, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. acceptance of and attitude toward f COVID-19 vaccination [5 months]

    Secondary Outcome Measures

    1. the impact of the COVID-19 pandemic [5 months]

    2. perception of risk related to the COVID-19 pandemic [5 months]

    3. Improvement of vaccination status among pregnant women [5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • pregnant women at any gestational age
    Exclusion Criteria:
    • Covid 19 suspicious patients at time of survey.

    • patients refusing survey

    • obstetric emergency.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bassiony Dabian, lecturer of obstetrics and gynecology, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05258760
    Other Study ID Numbers:
    • covid vaccine in pregnancy
    First Posted:
    Feb 28, 2022
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2022