NCT06770465

Maternal Use of Antibiotics and the Risk of Congenital Malformations

Maternal Use of Antibiotics and the Risk of Congenital Malformations: a Study Using Spontaneous Reporting Data and a Population-based Cohort Data From the US, Canada and China

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 850,000 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Antibiotics are widely used during pregnancy to prevent or treat infections, yet concerns remain regarding their fetal safety. Drawing on data from spontaneous reporting databases and cohort studies, this study aims to explore potential associations between exposure to various antibiotic classes during pregnancy and congenital malformations. Data were collected from publicly available reports in the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), the Canada Vigilance Adverse Reaction (CVAR) database, and a population-based retrospective cohort in Xiamen, China. By applying multiple signal detection methods, we identified potential risk signals linking different antibiotic classes to organ-system-specific congenital malformations. For antibiotics showing positive signals, we further utilized a pregnancy medication cohort in Xiamen and applied causal inference techniques to estimate the adjusted relative risk of congenital malformations associated with first-trimester exposure to these antibiotics. Several sensitivity analyses-including both negative- and positive-control analyses-will also be performed.

Conditions

• Congenital Malformations

Interventions

Type	Name	Description
DRUG	Different categories of antibiotics	Use of different categories of antibiotics during pregnancy, such as quinolones and macrolides.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study