Maternal Use of Antibiotics and the Risk of Congenital Malformations

NCT ID: NCT06770465

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 850000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-30

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.

Conditions

Congenital Malformations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Use of antibiotics during pregnancy in FAERS and CVAR databases

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.

Different categories of antibiotics

Intervention Type: DRUG

Use of different categories of antibiotics during pregnancy, such as quinolones and macrolides.

Use of antibiotics during pregnancy in a cohort in Xiamen, China

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).

Different categories of antibiotics

Intervention Type: DRUG

Use of different categories of antibiotics during pregnancy, such as quinolones and macrolides.

Interventions

Different categories of antibiotics

Use of different categories of antibiotics during pregnancy, such as quinolones and macrolides.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Sun, PhD

Role: STUDY_CHAIR

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

Locations

The West China Hospital of Sichuan university

Chengdu, Sichuan, China

Countries

China

Other Identifiers

Antibiotics and BDs

Identifier Type: -

Identifier Source: org_study_id