NCT06180447

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150,000 (estimated)
• Sponsor: Sun Xin · Academic / Other
• Sex: Female
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-03-30
• First posted: 2023-12-22
• Last updated: 2024-05-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study