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Clinical trial

Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes

ID
Name
Vaccine registry study
Description
Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-12-31
Trial end
2025-03-30
Status
Active (not recruiting)
Treatment
Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine
Exposure was defined as use of the vaccine 90 days before the last menstrual period and during pregnancy.
Size
150000
Primary endpoint
Birth defects
From pregnancy to 42 days after delivery
Eligibility criteria
Inclusion Criteria: * All pregnant women in Xiamen who registry in our database. Exclusion Criteria: * Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 150000, 'type': 'ESTIMATED'}}
Updated at
2024-05-07

1 organization

1 product

1 indication

Organization
Sun Xin
Product
Hepatitis B vaccine
Indication
Adverse Vaccine Reaction