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AzTrials

COVID-19NCT05258760

Covid 19 Vaccine Acceptance in Egyptian Pregnant Women

An observational study of COVID-19, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
COVID-19
How many people
1,100 participants
Where
No sites listed yet
Study dates
26 Feb 2022to Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: 1100 pregnant women attending at kasr Alainy obstetric outpatient clinic

Who may be able to join

  • pregnant women at any gestational age

Who cannot join

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

About this study

Official title: Covid Vaccine Acceptance Among Egyptian Pregnant Women

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

Read the 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)

Conditions
COVID-19
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. acceptance of and attitude toward f COVID-19 vaccination

    Measured: 5 months

Secondary outcomes (3)

  1. the impact of the COVID-19 pandemic

    Measured: 5 months

  2. perception of risk related to the COVID-19 pandemic

    Measured: 5 months

  3. Improvement of vaccination status among pregnant women

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start26 Feb 2022 (estimated)
  3. Primary completionJun 2022 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258760
Sponsor's protocol ID
covid vaccine in pregnancy
Status last verified
Feb 2022
First submitted
25 Feb 2022
Last updated
28 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28890190

  • 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.

    PubMed 25444814

  • 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.

    PubMed 33163000

  • 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.

  • 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.

    PubMed 22643216

  • 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.

    PubMed 32873575

  • 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.

  • 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.

    PubMed 32428965

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

acceptance of and attitude toward f COVID-19 vaccination (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258760, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.

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