Status:
ACTIVE_NOT_RECRUITING
Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study
Lead Sponsor:
West China Hospital
Collaborating Sponsors:
Xiamen Health Commission
Xiamen Health and Medical Big Data Center
Conditions:
Pregnancy
Birth Defects
Eligibility:
FEMALE
15-60 years
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 incre...
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 the...
Eligibility Criteria
Inclusion
- Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.
Exclusion
- (1) those with the first antenatal visit occurring after 20 gestational weeks, (2) those without timing records of the last menstrual period or delivery dates, (3) those with known factors related to birth defects (e.g.,syphilis positive, epilepsy), (4) those prescribed known medications associated with birth defects (e.g.,dezocine, diazepam).
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200000 Patients enrolled
Trial Details
Trial ID
NCT06048276
Start Date
January 1 2023
End Date
December 31 2024
Last Update
May 7 2024
Active Locations (1)
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1
Xiamen Health and Medical Big Data Center
Xiamen, Fujian, China, 361008