Clinical trial NCT05258760: Covid 19 Vaccine Acceptance in Egyptian Pregnant Women
Official title: Covid Vaccine Acceptance Among Egyptian Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1100 pregnant women attending at kasr Alainy obstetric outpatient clinic

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

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)

Eligibility criteria: Inclusion Criteria:

* pregnant women at any gestational age

Exclusion Criteria:

* Covid 19 suspicious patients at time of survey.
* patients refusing survey
* obstetric emergency.

Primary outcomes:
measure: acceptance of and attitude toward f COVID-19 vaccination
timeFrame: 5 months
Secondary outcomes:
measure: the impact of the COVID-19 pandemic
timeFrame: 5 months
measure: perception of risk related to the COVID-19 pandemic
timeFrame: 5 months
measure: Improvement of vaccination status among pregnant women
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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citation: 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
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