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Purpose <p>Doxycycline is frequently prescribed during pregnancy, yet evidence on fetal safety is inconsistent and often excludes non-live births. We assessed whether exposure during the first or third trimester is associated with major congenital malformations or late-pregnancy adverse outcomes in a population-based cohort that also included stillbirths and terminations.</p> Methods <p>Using data from Clalit Health Services Southern district, we identified 265,686 pregnancies in women aged 15–45 years (from 1998 to 2017). Pharmacy records classified doxycycline dispensation in the first trimester (≤ 13 weeks) or third trimester (≥ 27 weeks). Crude and adjusted negative-binomial models estimated relative risks (RRs) for total and organ-specific major congenital malformations diagnosed up to age 1 year and for perinatal mortality, preterm birth, low/very-low birthweight, and low Apgar scores. Sensitivity analyses explored dose-response relations and propensity-score-matched cohorts.</p> Results <p>Among 2,696 first-trimester exposures, major malformations occurred in 7.7% versus 7.0% of 262,990 unexposed pregnancies (SMD = 0.03, <i>p</i> = 0.17). No association with major malformations was observed in both crude (Crude Relative Risk (RR) = 1.10; 95% CI 0.96–1.27) and adjusted (Adjusted RR = 1.07; 95% CI 0.93–1.23) analyses, nor by organ-specific sub-groups. Third-trimester exposure (<i>n</i> = 112) was linked to a higher risk of very-low birthweight, while other late-pregnancy outcomes were comparable to unexposed pregnancies.</p> Conclusion <p>First-trimester doxycycline use was not associated with increased major congenital malformation risk, and most late-pregnancy outcomes were unaffected. These findings support the relative safety of doxycycline when clinically indicated during pregnancy.</p>

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Doxycycline safety during pregnancy: a large population-based cohort of pregnancies

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月22日

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  • Itamar Ben Shitrit,
  • Daphna Idan,
  • Ariel Avraham Hasidim,
  • Tal Michael,
  • Amalia Levy,
  • Gali Pariente,
  • Eitan Lunenfeld,
  • Sharon Daniel

摘要

Purpose

Doxycycline is frequently prescribed during pregnancy, yet evidence on fetal safety is inconsistent and often excludes non-live births. We assessed whether exposure during the first or third trimester is associated with major congenital malformations or late-pregnancy adverse outcomes in a population-based cohort that also included stillbirths and terminations.

Methods

Using data from Clalit Health Services Southern district, we identified 265,686 pregnancies in women aged 15–45 years (from 1998 to 2017). Pharmacy records classified doxycycline dispensation in the first trimester (≤ 13 weeks) or third trimester (≥ 27 weeks). Crude and adjusted negative-binomial models estimated relative risks (RRs) for total and organ-specific major congenital malformations diagnosed up to age 1 year and for perinatal mortality, preterm birth, low/very-low birthweight, and low Apgar scores. Sensitivity analyses explored dose-response relations and propensity-score-matched cohorts.

Results

Among 2,696 first-trimester exposures, major malformations occurred in 7.7% versus 7.0% of 262,990 unexposed pregnancies (SMD = 0.03, p = 0.17). No association with major malformations was observed in both crude (Crude Relative Risk (RR) = 1.10; 95% CI 0.96–1.27) and adjusted (Adjusted RR = 1.07; 95% CI 0.93–1.23) analyses, nor by organ-specific sub-groups. Third-trimester exposure (n = 112) was linked to a higher risk of very-low birthweight, while other late-pregnancy outcomes were comparable to unexposed pregnancies.

Conclusion

First-trimester doxycycline use was not associated with increased major congenital malformation risk, and most late-pregnancy outcomes were unaffected. These findings support the relative safety of doxycycline when clinically indicated during pregnancy.