Safety of SARS-CoV-2 vaccination during pregnancy (Covid-19)– Collection and analysis of pregnancy course data by the Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie

• Conditions: otherICD10 O09.-!: duration of pregnancy < 37 weeks ICD10 P05.-: Newborns too light for their gestational age; Q89.9; O03; P95; Congenital malformation, unspecified; Spontaneous abortion; Fetal death of unspecified cause

• Registration Number: DRKS00025255
• Lead Sponsor: Paul-Ehrlich-Institut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

Prospectively followed pregnancy courses with completed follow-up

Exclusion Criteria

no

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Possible adverse effects on pregnancy and possible teratogenic effects of the SARS-Cov-2 vaccine evaluated in terms of the rate of spontaneous abortion and major birth defects. Outcomes are assessed with a questionnaire eight weeks after the estimated date of birth.

Secondary Outcome Measures

Name	Time	Method
Effect of the SARS-CoV-2 vaccination on<br><br>-the total rate of spontaneous abortions/intrauterine deaths/stillbirths after the vaccination compared to a non-vaccinated control cohort. <br>- the frequency of preterm deliveries, fetal growth retardationlow, and neonatal disorders more frequent after the SARS-CoV-2 vaccination than in a non-vaccinated comparison cohort<br>-the rate of complications in the course of pregnancy after the vaccination compared to a non-vaccinated cohort.<br>All outcomes are assessed with a questionnaire eight weeks after the estimated date of birth <br>