Pregnancy Clinical Trial
Official title:
Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study
Verified date | May 2024 |
Source | West China Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 200000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 60 Years |
Eligibility | Inclusion Criteria: - Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included. Exclusion Criteria: - (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). |
Country | Name | City | State |
---|---|---|---|
China | Xiamen Health and Medical Big Data Center | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
West China Hospital | Xiamen Health and Medical Big Data Center, Xiamen Health Commission |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall birth defects (excluding chromosomal malformations) | Number of births with birth defects | From conception to 42 days after delivery | |
Secondary | National monitored 23 main types of birth defects | Number of births with 23 major births defects defined by National Health Standard Criteria in the China national universal surveillance system | From conception to 42 days after delivery |
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