Trial document




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  DRKS00025255

Trial Description

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Title

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

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Trial Acronym

SARS-CoV-2 PregVac

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URL of the Trial

https://www.embryotox.de/das-institut/forschung/projekte/

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Brief Summary in Lay Language

After research on the development of vaccines against the new coronavirus SARS-CoV-2 has been carried out worldwide, several vaccines are currently available that are approved in the EU.
In the case of the newly approved COVID-19 vaccines, the risk profile in pregnancy for the unborn child is not yet sufficiently known. The aim of this study is therefore to assess the safety of the COVID-19 vaccination on pregnancy course and pregnancy outcome.

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Brief Summary in Scientific Language

To assess the risk of the immunization against SARS-CoV-2 for the unborn child, pregnancy course data and newborn's state after a SARS-CoV-2 vaccination need to be systematically collected and analyzed. This surveillance study aims to identify potential risks due to the vaccination for spontaneous abortions, stillbirth, complications during pregnancy, preterm birth, intrauterine growth retardation, birth defects, and neonatal anomalies. The study is a prospective observational study. For assessing primary and secondary objectives, the risk of adverse events in the exposed study cohort will be compared with the risk in an unexposed control cohort. The exposed cohort consists of women vaccinated during or shortly before their pregnancy and who have contacted the Pharmakovigilanz- und Beratungszentrum (PVZ) Embryonaltoxikologie. At the first contact, anamnestic and demographic data is collected by standardized procedures. With a follow-up questionnaire, information about the pregnancy course, the outcome, and the state of the newborn is collected.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

privacy protection

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Organizational Data

  •   DRKS00025255
  •   2021/05/25
  •   [---]*
  •   yes
  •   Approved
  •   EA2/081/21, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

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

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

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/04/28
  •   4000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Prospectively followed pregnancy courses with completed follow-up

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Exclusion Criteria

no

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Addresses

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    • Paul-Ehrlich-Institut
    • Paul-Ehrlich-Straße 51-59
    • 63225  Langen
    • Germany
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    • Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Leitung)Institut für Klinische Pharmakologie und ToxikologieCharité - Universitätsmedizin Berlin, Campus Virchow Klinikum
    • Ms.  PD Dr. med.  Katarina  Dathe 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieInstitut für Klinische Pharmakologie und ToxikologieCharité - Universitätsmedizin Berlin, Campus Virchow Klinikum
    • Ms.  Dr. med.  Angela  Kayser 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • 53107  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.