Preterm prelabor rupture of membranes (PPROM) is managed expectantly in many centers with antibiotic therapy intended to reduce maternal and neonatal infectious complications and potentially prolong latency. This retrospective historical cohort study aimed to compare maternal and neonatal outcomes in women with PPROM between 24+0 and 34+6 weeks who received either standard ampicillin-erythromycin or an institutional alternative regimen combining ampicillin, ceftriaxone, and clarithromycin.
The investigation was a retrospective cohort conducted at a tertiary referral center in Cali, Colombia. The study period spanned January 2019 through December 2024. Antibiotic practice at the center shifted over time: ampicillin-erythromycin was used from 2019 to 2022, and the ampicillin-ceftriaxone-clarithromycin regimen was adopted from 2023 to 2024.
The cohort included women with singleton pregnancies and confirmed PPROM between 24+0 and 34+6 weeks. The total sample comprised 136 women: 64 received ampicillin-erythromycin and 72 received the ampicillin-ceftriaxone-clarithromycin regimen. The source reports these inclusion windows and overall cohort size but does not present additional baseline demographic or obstetric characteristic details in the abstract.
Two expectant-management antibiotic approaches were compared:
The abstract does not provide dosing schedules, duration of therapy, or timing relative to membrane rupture; those details were not reported in the source abstract.
Primary outcomes included measures of maternal infectious morbidity and early-onset neonatal sepsis. Maternal infectious outcomes specifically reported in the abstract were clinical chorioamnionitis, maternal sepsis, and postpartum endometritis. Latency (time from rupture to delivery) was a secondary outcome assessed via the restricted mean time to delivery (RMTD) derived from Kaplan–Meier curves.
The authors used Kaplan–Meier methods to estimate latency and reported the restricted mean time to delivery (RMTD). Comparisons between groups were tested with P values reported for categorical outcomes. Multivariable adjustment was performed to identify independent associations, though the abstract does not list which covariates were included in those models.
Compared with ampicillin-erythromycin, the ampicillin-ceftriaxone-clarithromycin regimen was associated with lower proportions of reported maternal infectious events in the cohort:
After multivariable adjustment, the alternative regimen remained independently associated with a reduction in clinical chorioamnionitis.
The rate of early-onset neonatal sepsis was lower in the ampicillin-ceftriaxone-clarithromycin group (46.5%) compared with the ampicillin-erythromycin group (66.1%), with a reported unadjusted P value of 0.039. However, the abstract states that the association with early-onset neonatal sepsis was attenuated after multivariable adjustment and should be interpreted as exploratory rather than definitive.
The authors report that multivariable adjustment preserved an independent association between the alternative regimen and reduced clinical chorioamnionitis. For early-onset neonatal sepsis, the observed unadjusted difference lost strength after adjustment; specific adjusted effect estimates and the covariates included in the models are not reported in the abstract and therefore were not available from the source.
Latency, measured as the restricted mean time to delivery (RMTD) from Kaplan–Meier curves, was numerically longer in the ampicillin-ceftriaxone-clarithromycin group. The RMTD difference was 1.39 days with a 95% confidence interval of −2.40 to 5.18 and a P value of 0.471, indicating no statistically significant difference in latency between regimens in this cohort.
In this retrospective cohort of expectantly managed PPROM before 35 weeks, the institutional alternative regimen of ampicillin-ceftriaxone-clarithromycin was associated with lower rates of several maternal infectious outcomes and a lower unadjusted rate of early-onset neonatal sepsis compared with ampicillin-erythromycin. The reduction in clinical chorioamnionitis remained significant after adjustment; the neonatal sepsis finding was attenuated after adjustment and considered exploratory.
The authors recommend prospective studies to confirm efficacy and safety, to evaluate impacts on antimicrobial resistance, and to assess long-term neonatal outcomes. The abstract does not provide detailed safety data, regimen dosing, or long-term follow-up; those elements would require consulting the full text or further research.