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

Active, not recruiting

• Conditions: Drug Exposures; Pregnancy; Birth Defects
• Interventions: Drug: Herbal medicines (e.g., Yunkang granules, Duzhong granules)

• Registration Number: NCT06048276
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug exposure	Herbal medicines (e.g., Yunkang granules, Duzhong granules)	Herbal medicines

Primary Outcome Measures

Name	Time	Method
Overall birth defects (excluding chromosomal malformations)	From conception to 42 days after delivery	Number of births with birth defects

Secondary Outcome Measures

Name	Time	Method
National monitored 23 main types of birth defects	From conception to 42 days after delivery	Number of births with 23 major births defects defined by National Health Standard Criteria in the China national universal surveillance system

Trial Locations

Locations (1)

Xiamen Health and Medical Big Data Center; 🇨🇳 Xiamen, Fujian, China