Covid 19 Vaccine Acceptance in Egyptian Pregnant Women

COVID-19 Clinical Trial

Official title:

Covid Vaccine Acceptance Among Egyptian Pregnant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05258760
• Other study ID #: covid vaccine in pregnancy
• Status: Not yet recruiting
• Start date: February 26, 2022
• Est. completion date: June 2022

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnant women at any gestational age

Exclusion Criteria:

• Covid 19 suspicious patients at time of survey.

• patients refusing survey

• obstetric emergency.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (12)

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.

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.

Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320. — View Citation

Durrheim DN, Crowcroft NS, Strebel PM. Measles - The epidemiology of elimination. Vaccine. 2014 Dec 5;32(51):6880-6883. doi: 10.1016/j.vaccine.2014.10.061. Epub 2014 Nov 4. Review. — View Citation

Hinman AR. The eradication of Polio: Have we succeeded? Vaccine. 2017 Oct 9;35(42):5519-5521. doi: 10.1016/j.vaccine.2017.09.015. Epub 2017 Sep 8. — View Citation

Prematunge C, Corace K, McCarthy A, Nair RC, Pugsley R, Garber G. Factors influencing pandemic influenza vaccination of healthcare workers--a systematic review. Vaccine. 2012 Jul 6;30(32):4733-43. doi: 10.1016/j.vaccine.2012.05.018. Epub 2012 May 27. Review. — View Citation

Sharma O, Sultan AA, Ding H, Triggle CR. A Review of the Progress and Challenges of Developing a Vaccine for COVID-19. Front Immunol. 2020 Oct 14;11:585354. doi: 10.3389/fimmu.2020.585354. eCollection 2020. Review. — View Citation

Smith DD, Pippen JL, Adesomo AA, Rood KM, Landon MB, Costantine MM. Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries. Am J Perinatol. 2020 Jun;37(8):792-799. doi: 10.1055/s-0040-1712103. Epub 2020 May 19. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceptance of and attitude toward f COVID-19 vaccination		5 months
Secondary	the impact of the COVID-19 pandemic		5 months
Secondary	perception of risk related to the COVID-19 pandemic		5 months
Secondary	Improvement of vaccination status among pregnant women		5 months