ABSTRACT
Background
Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated
with significantly-reduced intra-amniotic infection and improved neonatal outcome,
although data are insufficient to determine the optimal antibiotic regimen. Ampicillin
resistance has changed the epidemiology of neonatal sepsis.
Objective
We compared the efficacy of two antibiotic regimens in prolonging the latency period
in women with PPROM.
Study Design
This randomized-controlled trial was conducted in three tertiary university-affiliated
hospitals; 124 women with PPROM<37 weeks were randomized into two antibiotic prophylactic
protocols: ampicillin + roxithromycin vs. cefuroxime + roxithromycin. We measured
and compared latency period length, neonatal adverse outcomes and maternal infectious
morbidity including intrauterine infection, intrapartum fever, postpartum antibiotic
treatment, endometritis and wound infection.
Results
Maternal infectious morbidity was higher in the ampicillin versus cefuroxime group
(17.7% versus 6.5%, p-value one sided=0.048). The pathogen distribution among placenta,
membrane, cord and uterine cultures differed between the groups (p=0.017). Enterobacteriaceae
spp. cultures were identified in 68.6% of the cultures in the ampicillin group versus
43.2% in the cefuroxime group (p=0.036). The composite neonatal adverse outcome was
higher in the ampicillin than the cefuroxime group: 55 (88.7%) versus 46 (74.2%),
p-value one-sided=0.03. The proportion of primiparas with a latency period above 4
days was significantly higher in the cefuroxime versus the ampicillin group (P=0.025,
OR=3.69 95% CI (1.175,11.607)).
Conclusions
In combination with roxithromycin, cefuroxime compared to ampicillin, as a prophylactic
for PPROM<37, showed longer pregnancy in primiparas and less maternal and neonatal
morbidity. Further larger studies are needed to support our results.
Keywords
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Article info
Publication history
Accepted:
January 31,
2023
Received:
January 27,
2023
Publication stage
In Press Accepted ManuscriptFootnotes
Funding: No funding was received for this research ClinicalTrials.gov Identifier: NCT02819570. https://clinicaltrials.gov/ct2/show/NCT02819570
Data Sharing: Raw data were generated at Galilee Medical Center. The data derived that support the findings of this study are available from the corresponding author [MFW] on request.
Paper presentation information: Oral presentation during the 43nd Annual Pregnancy Meeting™ SMFM on February 9, 2023, San-Francisco California.
Disclosure statement: The authors report no conflicts of interest.
Condensation: Combined with roxithromycin, cefuroxime as a prophylactic for preterm pre-labor rupture of membranes <37 showed longer pregnancy and less maternal and neonatal morbidity than ampicillin.
Identification
Copyright
© 2023 Elsevier Inc. All rights reserved.
