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

Sun Xin

Status

Active, not recruiting

Conditions

Vaccine Adverse Reaction

Treatments

Biological: Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT06180447

Vaccine registry study

Details and patient eligibility

About

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)

Full description

We will develop a vaccination cohort by linking population-based pregnancy registries (i.e., REPRESENT) with population-based vaccine databases.

The researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. This study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. Poisson regression based on propensity scores will be used to estimate the relative risk. To ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.

Enrollment

150,000 estimated patients

Sex

Female

Ages

14 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria