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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse pregnancy outcomes | Including gestational diabetes, fetal distress, premature rupture of membranes, low birth weight and so on. | From pregnancy to 42 days after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Xin Sun, PhD | Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The West China Hospital of Sichuan university | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40984047 | Derived | 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. |
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The datasets are not publicly available, but are available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| D011819 | Rabies Vaccines |
| D053918 | Papillomavirus Vaccines |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| D045424 |
| Complex Mixtures |