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Does early pregnancy exposure to macrolide antibiotics lead to major birth defects? A systematic review and
Jing Zhang1, Quanhong Li2, Yanbin Yang1
1Department of Obstetrics, Kunming City Maternal and Child Health Hospital, Kunming, China.
Background:
Macrolide antibiotics are frequently used to treat infections in women during early pregnancy. However, the association between early pregnancy exposure to macrolide antibiotics and major birth defects remains uncertain. Clarifying this risk is crucial for public health and clinical decision-making.
Methods:
This study systematically searched five databases-Web of Science, PubMed, Embase, Cochrane, and Scopus-for studies exploring the relationship between early pregnancy exposure to macrolide antibiotics and major birth defects. Two independent researchers conducted the literature screening, data extraction, and bias risk assessment. Meta-analysis was performed using the metan command in STATA 16 to pool the data.
Results:
Nine studies were included, selected from 6,002 articles, comprising seven cohort studies and two case-control studies. These studies covered 40,218 patients exposed to macrolide antibiotics in early pregnancy. Due to low heterogeneity among studies, a fixed-effects model was used for the meta-analysis. The results showed no significant association between early pregnancy exposure to macrolide antibiotics and the risk of major birth defects (OR = 1.05, 95% CI [0.97, 1.13]). Subgroup analysis of 11 types of major birth defects also found no such association, particularly for birth defects of the heart (OR = 1.09, 95% CI [0.96, 1.23]). Low heterogeneity and reduced risk of bias further enhanced the reliability of the findings.
Conclusion:
Existing evidence suggests that early pregnancy use of macrolide antibiotics does not increase the risk of major birth defects. In clinical practice, healthcare providers and pregnant women can use these antibiotics cautiously based on the specific infection situation.
Insights
Early pregnancy use of macrolide antibiotics does not increase the risk of major birth defects. This systematic review and meta-analysis found no significant association, offering reassurance for clinical practice.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Public Health
Background:
- Macrolide antibiotics are commonly prescribed during early pregnancy.
- The safety of macrolide use in early pregnancy regarding major birth defects requires clarification.
- Accurate risk assessment is vital for clinical decisions and public health guidance.
Purpose of the Study:
- To systematically evaluate the association between early pregnancy exposure to macrolide antibiotics and major birth defects.
- To synthesize evidence from existing studies through meta-analysis.
- To provide evidence-based information for healthcare providers and pregnant women.
Main Methods:
- Comprehensive literature search across five major databases (Web of Science, PubMed, Embase, Cochrane, Scopus).
- Systematic screening, data extraction, and risk of bias assessment by two independent researchers.
- Meta-analysis using a fixed-effects model in STATA 16 due to low heterogeneity.
Main Results:
- Nine studies involving 40,218 patients were included.
- No significant association was found between early pregnancy macrolide exposure and major birth defects (OR = 1.05, 95% CI [0.97, 1.13]).
- Subgroup analyses, including for cardiac defects, also showed no increased risk.
Conclusions:
- Current evidence indicates that macrolide antibiotic use in early pregnancy does not elevate the risk of major birth defects.
- Healthcare providers can cautiously prescribe macrolides based on infection severity.
- Findings support the safe use of macrolides when clinically indicated during early pregnancy.
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