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

Active, not recruiting

• Conditions: Vaccine Adverse Reaction

• Registration Number: NCT06180447
• Lead Sponsor: Sun Xin

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.

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2023-12-22
• Study Start: 2024-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth defects	From pregnancy to 42 days after delivery	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse pregnancy outcomes	From pregnancy to 42 days after delivery	Including gestational diabetes, fetal distress, premature rupture of membranes, low birth weight and so on.

Trial Locations

Locations (1)

The West China Hospital of Sichuan university; 🇨🇳 Chengdu, Sichuan, China