Epidemiology (Cambridge, Mass.) · 2025
Antibiotics and Preterm Delivery: The Prevalent New-user Cohort Design to Resolve Immortal Time Bias.
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Galmiche Simon, Comin Eros, Dell'Aniello Sophie, Balayla Jacques, Suissa Samy
Аннотация
BACKGROUND: Observational studies of the association between antibiotics and preterm delivery report conflicting findings, with some potentially affected by immortal time bias. We assessed the effects of third-trimester antibiotic use on preterm delivery and low birthweight, using a study design that accounts for immortal time bias.
METHODS: We used the UK's Clinical Practice Research Datalink to identify pregnant females aged 12-50, over the period 2002 to 2016, reaching 27 weeks of gestation without antibiotic use until that point. We applied the prevalent new-user design, matching each third-trimester antibiotic initiator with a reference nonuser at the same gestational day, using time-conditional propensity scores. The 2 matched groups were compared on the incidence of preterm delivery and low birthweight. The full cohort was also analyzed with antibiotic use considered as time-fixed and time-varying exposures.
RESULTS: The cohort included 207,027 pregnancies, with 16,865 initiating antibiotics matched to 16,865 nonusers. The hazard ratio (HR) of preterm delivery with third-trimester antibiotic use was 1.14 [95% confidence interval (CI): 1.04, 1.24], compared with nonuse. With time-fixed exposure, subject to immortal time bias, the HR was 0.78 (95% CI: 0.73, 0.83), while with time-varying exposure, the HR was 1.23 (95% CI: 1.16, 1.32). The HR of low birthweight with antibiotic initiation was 1.07 (95% CI: 0.93, 1.25) compared with 0.91 (95% CI: 0.83, 1.00) under the time-fixed approach.
CONCLUSIONS: Using the prevalent new-user design, which emulates a randomized trial, antibiotic use late in pregnancy was associated with a modestly increased incidence of preterm delivery. Previous inconclusive studies may have resulted from observational methods that introduced, or insufficiently addressed, immortal time bias.
METHODS: We used the UK's Clinical Practice Research Datalink to identify pregnant females aged 12-50, over the period 2002 to 2016, reaching 27 weeks of gestation without antibiotic use until that point. We applied the prevalent new-user design, matching each third-trimester antibiotic initiator with a reference nonuser at the same gestational day, using time-conditional propensity scores. The 2 matched groups were compared on the incidence of preterm delivery and low birthweight. The full cohort was also analyzed with antibiotic use considered as time-fixed and time-varying exposures.
RESULTS: The cohort included 207,027 pregnancies, with 16,865 initiating antibiotics matched to 16,865 nonusers. The hazard ratio (HR) of preterm delivery with third-trimester antibiotic use was 1.14 [95% confidence interval (CI): 1.04, 1.24], compared with nonuse. With time-fixed exposure, subject to immortal time bias, the HR was 0.78 (95% CI: 0.73, 0.83), while with time-varying exposure, the HR was 1.23 (95% CI: 1.16, 1.32). The HR of low birthweight with antibiotic initiation was 1.07 (95% CI: 0.93, 1.25) compared with 0.91 (95% CI: 0.83, 1.00) under the time-fixed approach.
CONCLUSIONS: Using the prevalent new-user design, which emulates a randomized trial, antibiotic use late in pregnancy was associated with a modestly increased incidence of preterm delivery. Previous inconclusive studies may have resulted from observational methods that introduced, or insufficiently addressed, immortal time bias.