NCT05258760

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

February 25, 2022

Last Update Submit

February 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • acceptance of and attitude toward f COVID-19 vaccination

    5 months

Secondary Outcomes (3)

  • the impact of the COVID-19 pandemic

    5 months

  • perception of risk related to the COVID-19 pandemic

    5 months

  • Improvement of vaccination status among pregnant women

    5 months

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

1100 pregnant women attending at kasr Alainy obstetric outpatient clinic

You may qualify if:

  • pregnant women at any gestational age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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. No abstract available.

    PMID: 28890190BACKGROUND
  • 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.

    PMID: 25444814BACKGROUND
  • 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.

    PMID: 33163000BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22643216BACKGROUND
  • 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.

    PMID: 32873575BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32428965BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

February 25, 2022

First Posted

February 28, 2022

Study Start

February 26, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

February 28, 2022

Record last verified: 2022-02