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

December 21, 2023 updated by: Sun Xin
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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • The West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth defects
Time Frame: 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).
From pregnancy to 42 days after delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Xin

Investigators

  • Study Chair: Xin Sun, PhD, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vaccine registry study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets are not publicly available, but are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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