An observational study in Congenital Malformations, sponsored by West China Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by West China Hospital · Observational
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 850,000 is above the median of 153 across 446 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
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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
For the cohort study, all Xiamen pregnant women registered in the cohort were included
Exclusion Criteria:
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.
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
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
Use of different categories of antibiotics during pregnancy, such as quinolones and macrolides.
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
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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West China Hospital