Maternal Use of Antibiotics and the Risk of Congenital Malformations

Active, not recruiting

• Conditions: Congenital Malformations
• Interventions: Drug: Different categories of antibiotics

• Registration Number: NCT06770465
• Lead Sponsor: West China Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 850000

Inclusion Criteria

• For the spontaneous reporting data study, all adverse reactions reported by mothers were included.

For the cohort study, all Xiamen pregnant women registered in the cohort were included

Exclusion Criteria

• For studies using spontaneous reporting data, all adverse reaction reports unrelated to pregnant or postpartum women-including those occurring during the lactation period-were excluded.

For cohort studies, pregnant women who were lost to follow-up were excluded, and pregnant women who were exposed to factors known to be associated with congenital malformations were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Use of antibiotics during pregnancy in FAERS and CVAR databases	Different categories of antibiotics	When using the publicly available spontaneous adverse event reporting databases FAERS and CVAR, the exposure group consists of reports of adverse events in pregnant individuals who used different types of antibiotics, and the control group consists of other adverse event reports in which no antibiotics were used.
Use of antibiotics during pregnancy in a cohort in Xiamen, China	Different categories of antibiotics	When using the pregnant women cohort data from Xiamen, China, the exposure group consists of pregnant individuals who used the target antibiotics of interest, while the control group is either those who did not use any antibiotics (blank control) or those who used penicillin (positive control).

Primary Outcome Measures

Name	Time	Method
Congenital malformations	From pregnancy to 42 days after delivery	This study categorizes congenital malformation adverse events into 10 organ system specific congenital malformation (Q00-Q89) based on ICQ-10. Additionally, the cohort detected 22 congenital malformations mandated for surveillance in China and generated a composite outcome of total congenital malformation, that was a combination of all the above congenital anomalies.

Trial Locations

Locations (1)

The West China Hospital of Sichuan university; 🇨🇳 Chengdu, Sichuan, China