Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180447
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-12-12
Brief Title:
Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
Sponsor:
Sun Xin
Organization:
West China Hospital
Study Overview
Official Title:
Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Uing data from a population based cohort in China we will conduct retrospective cohort study to evaluate the risk of vaccine eg HPVinfluenzarabies vaccine administered during pregnancy especially during first trimester for adverse pregnancy outcomes eg birth defects preterm birth and low birth weight
Detailed Description:
We will develop a vaccination cohort by linking population-based pregnancy registries ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None