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

NCT06180447 | Active Not Recruiting FDA Drug

• 1 other identifier: Vaccine registry study
• Study Type: observational
• Target: 150,000
• Locations: 1 country
• Sites: 1

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)

Conditions

Vaccine Adverse Reaction

Keywords

Vaccine; birth defect; adverse pregnancy outcomes

Outcome Measures

Primary Outcomes (1)

• Birth defects

  BDs were defined as any prenatal malformation (including structural, functional, or metabolic disorders) diagnosed through systematic ultrasound or genetic testing during pregnancy and any malformation diagnosed by clinicians within 42 days of birth，which were coded according to the International Classification of Diseases, Tenth Revision (ICD-10) (Q00-Q99).

  From pregnancy to 42 days after delivery

Secondary Outcomes (1)

• Incidence of Adverse pregnancy outcomes

  From pregnancy to 42 days after delivery

Interventions

Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine BIOLOGICAL

Exposure was defined as use of the vaccine 90 days before the last menstrual period and during pregnancy.

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.

You may qualify if:

• All pregnant women in Xiamen who registry in our database.

You may not qualify if:

• Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.

Sponsors & Collaborators

• Sun Xin: lead

Study Sites (1)

The West China Hospital of Sichuan university

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 40984047 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Hepatitis B Vaccines; Rabies Vaccines; Papillomavirus Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Xin Sun, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor; director

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)