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

NCT06048276 | Active Not Recruiting

• 1 other identifier: HERB and BD
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Birth Defects; Drug Exposures

Keywords

Herbal medicines; Birth defects; Drug exposures; Cohort study

Outcome Measures

Primary Outcomes (1)

• Overall birth defects (excluding chromosomal malformations)

  Number of births with birth defects

  From conception to 42 days after delivery

Secondary Outcomes (1)

• National monitored 23 main types of birth defects

  From conception to 42 days after delivery

Study Arms (1)

Drug exposure

Herbal medicines

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

Interventions

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

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

Drug exposure

Eligibility Criteria

• Age: 15 Years - 60 Years
• Gender Eligibility Details: All pregnant women registered at the REPRESENT were enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Between January 2013 and December 2018, all pregnant women who registered at the REPRESENT in Xiamen was included in this cohort.

You may qualify if:

• Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.

You may not qualify if:

• (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).

Sponsors & Collaborators

• West China Hospital: lead
• Xiamen Health Commission: collaborator
• Xiamen Health and Medical Big Data Center: collaborator

Study Sites (1)

Xiamen Health and Medical Big Data Center

Xiamen, Fujian, 361008, China

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Plant Extracts

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Xin Sun, PHD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Chinese Evidence-based Medicine Center

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)