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Maternal Use of Antibiotics and the Risk of Congenital Malformations

NCT06770465 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 850000

Last updated 2025-01-13

No results posted yet for this study

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

DRUG

Different categories of antibiotics

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

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xin Sun, PhD · Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06770465 on ClinicalTrials.gov