Maternal Use of Antibiotics and the Risk of Congenital Malformations

NCT06770465 | Active Not Recruiting FDA Drug

• 1 other identifier: Antibiotics and BDs
• Study Type: observational
• Target: 850,000
• Locations: 1 country
• Sites: 1

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

Keywords

Antibiotic; Congenital malformation; Pregnancy; Spontaneous report; Cohort

Outcome Measures

Primary Outcomes (1)

• 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.

  From pregnancy to 42 days after delivery

Study Arms (2)

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.

Drug: Different categories of antibiotics

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).

Drug: Different categories of antibiotics

Interventions

Different categories of antibiotics DRUG

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

Use of antibiotics during pregnancy in FAERS and CVAR databases; Use of antibiotics during pregnancy in a cohort in Xiamen, China

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the spontaneous reporting studies, the study population was pregnant women who reported an adverse medication event during the study period, where the exposed population was pregnant women who reported an adverse event due to the use of a different type of antibiotic during the study period. For cohort studies, the study population was women who were pregnant during the study period and the exposed population was pregnant women who used different types of antibiotics during the study period

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

The West China Hospital of Sichuan university

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xin Sun, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CN (1)