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A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial
Maya Frank Wolf1, Inshirah Sgayer1, Dan Miron2
1Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.
Insights
Cefuroxime plus roxithromycin prolonged pregnancy in preterm pre-labor rupture of membranes (PPROM) and reduced gram-negative infections compared to ampicillin plus roxithromycin. This combination is recommended for PPROM management.
Area of Science:
- Obstetrics and Gynecology
- Neonatal Medicine
- Infectious Diseases
Background:
- Prophylactic antibiotics in preterm pre-labor rupture of membranes (PPROM) reduce intra-amniotic infections and improve neonatal outcomes.
- Optimal antibiotic regimens for PPROM remain undetermined.
- Rising rates of early-onset sepsis due to Escherichia coli and Klebsiella pneumoniae, coupled with ampicillin resistance, necessitate evaluating alternative antibiotic protocols.
Purpose of the Study:
- To compare the efficacy of two prophylactic antibiotic regimens in PPROM: ampicillin + roxithromycin versus cefuroxime + roxithromycin.
- To evaluate the impact of these regimens on prolonging pregnancy duration.
- To assess the reduction in infectious morbidity in neonates.
Main Methods:
- A multicenter, randomized, unblinded, controlled, prospective trial involving 84 women with PPROM.
- Comparison of two antibiotic prophylactic protocols: ampicillin + roxithromycin versus cefuroxime + roxithromycin.
- Data collected from December 2015 to December 2019.
Main Results:
- The cefuroxime + roxithromycin group demonstrated a significantly longer median latency period (4.63 days) compared to the ampicillin + roxithromycin group (2.3 days) (p = 0.039).
- Rates of neonatal intensive care unit admission, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support were similar between groups.
- Klebsiella pneumoniae cultures were significantly more frequent in the ampicillin + roxithromycin group; no Group B Streptococcus was detected.
Conclusions:
- Cefuroxime + roxithromycin is recommended as a first-line protocol for PPROM.
- This regimen effectively prolongs latency and reduces gram-negative early-onset sepsis.
- The findings support a shift in antibiotic choice for PPROM management.
Objectives:
Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity.
Design:
This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019.
Results:
The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive.
Conclusions:
To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM.
Clinical Trial Registration:
ClinicalTrials.gov Identifier: NCT02819570.
