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

Vaccine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06180447
• Other study ID #: Vaccine registry study
• Status: Active, not recruiting
• Start date: January 1, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150000
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaccine Adverse Reaction

Intervention

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.

Locations

Country	Name	City	State
China	The West China Hospital of Sichuan university	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Xin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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