Antenatal COVID 19 Vaccination and Pregnancy Outcomes

Antenatal COVID 19 VACCINATION and Pregnancy Outcomes

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

Study Overview

• Status: Recruiting
• Conditions: Effect of Drug
• Intervention / Treatment: Biological: pfizer, astrazeneca,moderna,sinofac

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 162

Contacts and Locations

• Study Contact: Name: sahar M Abdelmaksoud, masters; Phone Number: 01110065637; Email: saharabdelmaksoud@yahoo.com
• Study Contact Backup: Name: Amr S mahmoud, lecturer; Phone Number: +201010051381

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • AinShams University
    • Contact: sahar M Abdelmaksoud, masters; Phone Number: 01110065637; Email: saharabdelmaksoud@yahoo.com
    • Contact: Amr S Mahmoud, lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy loss	miscarrage or intrauterine fetal death	in first, second, third trimester

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fetal malformations	detected by detailed anomaly scan	at each trimester
pregnancy related hypertensive disorders	blood pressure higher than 140/90mmHg starting from 20 weeks of gestation	starting from 20 weeks of gestation

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed M Mamdouh, assistant professor, AinShams University; Study Director: Walid H Eltantawy, professor, AinShams University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No