Maternal Use of Antibiotics and the Risk of Congenital Malformations

N/AActive Not RecruitingNCT06770465

West China Hospital850,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

850,000

Conditions

Congenital Malformations

Interventions

Different categories of antibiotics

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Congenital malformations

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.

Time frame: From pregnancy to 42 days after delivery