Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study

NCT ID: NCT06048276

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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 (i.e., 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.

Conditions

Pregnancy; Birth Defects; Drug Exposures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Drug exposure

Herbal medicines

Herbal medicines (e.g., Yunkang granules, Duzhong granules)

Intervention Type: DRUG

Herbal medicines (e.g., Yunkang granules, Duzhong granules) exposure at the early gestation.

Interventions

Herbal medicines (e.g., Yunkang granules, Duzhong granules)

Herbal medicines (e.g., Yunkang granules, Duzhong granules) exposure at the early gestation.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Health Commission

UNKNOWN

Sponsor Role: collaborator

Xiamen Health and Medical Big Data Center

UNKNOWN

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

Director of Chinese Evidence-based Medicine Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Sun, PHD

Role: STUDY_CHAIR

Chinese Evidence-based Medicine Center, West China Hospital, Sichuan

Locations

Xiamen Health and Medical Big Data Center

Xiamen, Fujian, China

Countries

China

Other Identifiers

HERB and BD

Identifier Type: -

Identifier Source: org_study_id