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

N/AActive Not RecruitingNCT06180447

Sun Xin150,000 enrolled

Overview

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)

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 Type

OBSERVATIONAL

Enrollment

150,000

Conditions

Vaccine Adverse Reaction

Interventions

Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccineBIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The West China Hospital of Sichuan university

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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).

Time frame: From pregnancy to 42 days after delivery

Secondary Outcomes

Incidence of Adverse pregnancy outcomes

Including gestational diabetes, fetal distress, premature rupture of membranes, low birth weight and so on.

Time frame: From pregnancy to 42 days after delivery

Data from ClinicalTrials.gov

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