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NCT05401825 Clinical Trial

Antenatal COVID 19 Vaccination and Pregnancy Outcomes

Effect of Drug Clinical Trial

Official title:
Antenatal COVID 19 VACCINATION and Pregnancy Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05401825
Other study ID # 2311
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 18, 2022
Est. completion date September 2024

Study information
Verified date June 2022
Source Ain Shams University
Contact sahar M abdelmaksoud, masters
Phone 01110065637
Email saharabdelmaksoud@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Effect of COVID 19 vaccinations on pregnancy outcomes must be clear and identified to detect their safty

Description:

in this study we will discuss side effects of COVID 19 vaccine on pregnant women including the incidence of miscarrage , intrauterine fetal deaths, liquor abnormalities, preeclampsia, accidental hemorrhage , we also will follow up pregnant women who received any type of COVID 19 vaccine till delivery and discuss the effect of the vaccine on fetus and newborn

Recruitment information / eligibility
Status Recruiting
Enrollment 162
Est. completion date September 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy Exclusion Criteria: - comorbidities,women who refused participqtion,pregnant women with previous COVID 19 infection during current pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• pfizer, astrazeneca,moderna,sinofac
effect of COVID 19 vaccination on pregnancy outcomes

Locations
Country Name City State
Egypt Ainshams university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy loss miscarrage or intrauterine fetal death in first, second, third trimester
Secondary fetal malformations detected by detailed anomaly scan at each trimester
Secondary pregnancy related hypertensive disorders blood pressure higher than 140/90mmHg starting from 20 weeks of gestation starting from 20 weeks of gestation
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