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Covid 19 Vaccine Acceptance in Egyptian Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05258760
Recruitment Status : Not yet recruiting
First Posted : February 28, 2022
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Bassiony Dabian, Cairo University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To determine vaccine acceptance and hesitancy attitudes toward coronavirus disease 2019 (COVID-19) vaccines in Egyptian pregnant women.

Condition or disease
COVID-19

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Primary Outcome Measures :
  1. acceptance of and attitude toward f COVID-19 vaccination [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. the impact of the COVID-19 pandemic [ Time Frame: 5 months ]
  2. perception of risk related to the COVID-19 pandemic [ Time Frame: 5 months ]
  3. Improvement of vaccination status among pregnant women [ Time Frame: 5 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
1100 pregnant women attending at kasr Alainy obstetric outpatient clinic
Criteria

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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
4. Volkov S, World Health Organization. Vaccine hesitancy. https:// www.who.int/news-room/ spotl ight/ten-threa ts-to- globa l-healt h-in- 2019. Accessed April 25, 2020.
7. Abdelazim IA, AbuFaza M, Al-Munaifi S. COVID-19 positive woman presented with preterm labor: case report. Gynecol Obstet Reprod Med. 2021;202:1-3.
8. Dey M, Singh S, Tiwari R, Nair VG, Arora D, Tiwari S. Pregnancy outcome in first 50 sars-cov- 2 positive patients at our center. Gynecol Obstet Reprod Med. 2021;202:1-6.
9. Control CfD, Prevention. People with certain medical conditions. Morbidity and Mortality Weekly Report CDC. 2020. https://www. cdc.gov/coron aviru s/2019-ncov/ need-extra -preca ution s/peopl e-with- medic al-condi tions.html. Accessed September 7, 2020.
11. American College of Obstetricians and Gynecologists Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group in collaboration with Riley LE, Beigi R, Jamieson DJ, et al. Vaccinating pregnant and lactating patients against COVID-19. https://www.acog.org/clini cal/clini cal-guida nce/pract ice-advis ory/artic les/2020/12/vacci natin g-pregn ant-and- lacta ting-patie nts-again st-covid -19. Accessed April 25, 2020
12. Society for Maternal-Fetal Medicine. Society for Maternal-Fetal Medicine (SMFM) statement: SARS-CoV- 2 vaccination in pregnancy. https://s3.amazo naws.com/cdn.smfm.org/media/ 2591/SMFM_ Vacci ne_State ment_12-1- 20_( final ).pdf. Accessed April 25, 2020.

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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: February 28, 2022    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases