A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial. (July 2020)

• Record Type: Journal Article
• Authors: Wolf, Maya Frank; Sgayer, Inshirah; Miron, Dan; Krencel, Amir; Sheffer, Vered Fleisher; Idriss, Suraya Saied; Sammour, Rami N.; Peleg, David; Shachar, Inbar Ben; Rechnitzer, Hagai; Bornstein, Jacob
• Is Part Of: International journal of infectious diseases. Volume 96(2020)
• Page Start: 254
• Page End: 259
• Publication Date: 2020-07
• Subjects: Pre-labor rupture of membranes -- Prophylactic antibiotic treatment -- Latency period -- Early-onset sepsis -- Pathogens distribution; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2020.05.005
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: Escherichia coli and Klebsiella pneumonia early-onset sepsis rate is rising in PPROM. We compared two antibiotic regimens in PPROM for maternal and neonatal outcomes. Cefuroxime + roxithromycin is recommended as first-line protocol in PPROM. Cefuroxime + roxithromycin prolongs latency period. Cefuroxime + roxithromycin reduces gram-negative early onset sepsis. Abstract: 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.