Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048276
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-09-14
Brief Title:
Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects a Population-based Cohort Study
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects a Population-based Cohort Study
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:
Using data from a population-based medicine use cohort in Xiamen China this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects
Detailed Description:
Herbal medicines have a long history of use for pregnant women both in China and around the world However the safety of herbal medicines used at the early gestation is often questioned regarding their impact on offspring Therefore the aim of this study is to investigate whether miscarriage preventing herbal medicines associated with increased risk of birth defects
A large medication use cohort will be developed by linking a population-based pregnancy registry ie REPRESENT and a population-based pharmacy database which documented all prescriptions at both outpatients and inpatients from conception to delivery This cohort will include herbal medicines formula which were granted approval by the Chinese National Medical Products Administration
Using data from this cohort the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester This study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects A propensity score matching PSM based Poisson regression will be used to estimate the relative risk To ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses such as restricting the population to women with singleton pregnancies excluding individuals who had undergone in vitro fertilization IVF and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group
A large medication use cohort will be developed by linking a population-based pregnancy registry ie REPRESENT and a population-based pharmacy database which documented all prescriptions at both outpatients and inpatients from conception to delivery This cohort will include herbal medicines formula which were granted approval by the Chinese National Medical Products Administration
Using data from this cohort the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester This study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects A propensity score matching PSM based Poisson regression will be used to estimate the relative risk To ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses such as restricting the population to women with singleton pregnancies excluding individuals who had undergone in vitro fertilization IVF and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None