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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025255

Enrollment

4000

Registered

2021-05-25

Start date

2021-04-28

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

other ICD10 O09.-!: duration of pregnancy < 37 weeks ICD10 P05.-: Newborns too light for their gestational age Q89.9 O03 P95

Interventions

Group 1: Pregnant woman vaccinated with the SARS-CoV-2 influenza vaccine during or just before pregnancy. At first irrespective of the vaccine type. Group 2: Control: Pregnant women without vaccinatio

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Prospectively followed pregnancy courses with completed follow-up

Exclusion criteria

Exclusion criteria: no

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Effect of the SARS-CoV-2 vaccination on - the total rate of spontaneous abortions/intrauterine deaths/stillbirths after the vaccination compared to a non-vaccinated control cohort. - 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 - the rate of complications in the course of pregnancy after the vaccination compared to a non-vaccinated cohort. All outcomes are assessed with a questionnaire eight weeks after the estimated date of birth	—

Measure

Time frame

Effect of the SARS-CoV-2 vaccination on - the total rate of spontaneous abortions/intrauterine deaths/stillbirths after the vaccination compared to a non-vaccinated control cohort. - 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 - the rate of complications in the course of pregnancy after the vaccination compared to a non-vaccinated cohort. All outcomes are assessed with a questionnaire eight weeks after the estimated date of birth

—

Countries

Germany

Contacts

Public ContactAngela Kayser

Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieInstitut für Klinische Pharmakologie und ToxikologieCharité - Universitätsmedizin Berlin, Campus Virchow Klinikum

angela.kayser@charite.de030450525700

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026