PREGCOVAC-19: the follow up of pregnant women who received COVID-19 vaccination in the Dutch national vaccination program

Recruiting

• Conditions: COVID-19 Vaccine; SARS-COV-2; 10047438; 10010273

• Registration Number: NL-OMON51101
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Pregnant women (18 >= years) scheduled for COVID-19 vaccination

Exclusion Criteria

-No written informed consent
-Age < 18 years
-No knowledge of Dutch or English language

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The description of the antibody response in maternal blood during pregnancy and<br /><br>the number of placental antibodies transferred as determined in umbilical cord<br /><br>blood in relation to the gestational age at vaccination..</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The number of neonates with an antibody response as reflected by IgG response<br /><br>in cord blood in relation to the gestational age at vaccination will be<br /><br>analyzed using lineair regression.<br /><br>- The obstetric outcome in relation to the trimester in which vaccination was<br /><br>performed.</p><br>