Safety of SARS-CoV-2 vaccination during pregnancy – Collection and analysis of pregnancy course data by the Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Organizational Data
- DRKS-ID:
- DRKS00025255
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2021-05-25
- Last update in DRKS:
- 2023-11-09
- Registration type:
- Retrospective
Acronym/abbreviation of the study
SARS-CoV-2 PregVac
URL of the study
https://www.embryotox.de/das-institut/forschung/projekte/
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.
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.
Health condition or problem studied
- ICD10:
- Q89.9 - Congenital malformation, unspecified
- ICD10:
- O03 - Spontaneous abortion
- ICD10:
- P95 - Fetal death of unspecified cause
- Free text:
- other
- Free text:
- ICD10 O09.-!: duration of pregnancy < 37 weeks
- Free text:
- ICD10 P05.-: Newborns too light for their gestational age
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Pregnant woman vaccinated with the SARS-CoV-2 influenza vaccine during or just before pregnancy. At first irrespective of the vaccine type.
- Arm 2:
- Control: Pregnant women without vaccination
Endpoints
- 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.
- 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
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Charité – Universitätsmedizin Berlin Campus Virchow Klinikum Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie Berlin
Recruitment period and number of participants
- Planned study start date:
- 2023-10-01
- Actual study start date:
- 2021-04-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 4000
- Final Sample Size:
- 10000
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Prospectively followed pregnancy courses with completed follow-up
Exclusion Criteria
no
Addresses
Primary Sponsor
- Address:
- Paul-Ehrlich-InstitutPaul-Ehrlich-Straße 51-5963225 LangenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pei.de/cln_092/DE/home/de-node.html?__nnn=true
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Leitung)Institut für Klinische Pharmakologie und ToxikologieCharité - Universitätsmedizin Berlin, Campus Virchow KlinikumPD Dr. med. Katarina DatheAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450525702
- Fax:
- 0304507525920
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.embryotox.de/
Contact for Public Queries
- Address:
- Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieInstitut für Klinische Pharmakologie und ToxikologieCharité - Universitätsmedizin Berlin, Campus Virchow KlinikumDr. med. Angela KayserAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450525700
- Fax:
- 0304507525920
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.embryotox.de
Principal Investigator
- Address:
- Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Leitung)Institut für Klinische Pharmakologie und ToxikologieCharité - Universitätsmedizin Berlin, Campus Virchow KlinikumPD Dr. med. Katarina DatheAugustenburger Platz 113353 BerlinGermany
- Telephone:
- 030450525702
- Fax:
- 0304507525920
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.embryotox.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Gesundheit53107 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-03-10
- Ethics committee number:
- EA2/081/21
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-04-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- privacy protection
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry