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

NCT ID: NCT06180447

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 150000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-30

Brief Summary

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)

Detailed 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.

Conditions

Vaccine Adverse Reaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Xin

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

professor; director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin Sun, PhD

Role: STUDY_CHAIR

Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

Locations

The West China Hospital of Sichuan university

Chengdu, Sichuan, China

Countries

China

References

Guo J, Zhao P, Liu C, Liao M, Chen J, Ren Y, Yao G, Qian Y, Rong B, Qi H, Chen M, Zou K, Xiong Y, Sun X, Tan J. Peri-Conception Human Papillomavirus Vaccination Exposure and Risk of Birth Defects: A Population-Based Retrospective Cohort Study. Pharmacoepidemiol Drug Saf. 2025 Oct;34(10):e70222. doi: 10.1002/pds.70222.

Reference Type: DERIVED

PMID: 40984047 (View on PubMed)

Other Identifiers

Vaccine registry study

Identifier Type: -

Identifier Source: org_study_id