An observational study in Vaccine Adverse Reaction, sponsored by Sun Xin. Active, not recruiting at 1 site in China. Open to female participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Sun Xin · Observational
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.
This is the only study on the registry with Sun Xin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.
Exclusion Criteria:
Exposure was defined as use of the vaccine 90 days before the last menstrual period and during pregnancy.
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
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
Plan to share: No — The datasets are not publicly available, but are available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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