8 - Compared perinatal outcomes of two prophylactic antibiotic regimens for PPROM: A randomized controlled trial

Thursday, February 9, 2023

9:45 AM – 10:00 AM

Location: Moscone West, Level 3

Objective: 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. We compared the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity

Study Design: This randomized controlled trial included 124 women with PPROM < 37 weeks randomized into two antibiotic prophylactic protocols: ampicillin + roxithromycin vs. cefuroxime + roxithromycin. We measured and compared latency period length, neonatal adverse outcomes (culture-proven early-onset neonatal sepsis (EOS), admission to the neonatal intensive care unit (NICU), antibiotic treatment in NICU, performance of a sepsis workup) and maternal infectious morbidity including intrauterine infection, intrapartum fever, postpartum antibiotic treatment, endometritis and wound infection. Our study hypothesis, using one-sided p value, was that cefuroxime + roxithromycin will be associated with longer latency period

Results: Maternal infectious morbidity was higher in the ampicillin versus cefuroxime group (17.7% versus 6.5%, p =0.048). The pathogen distribution among placenta, membrane, cord and uterine cultures differed between the groups (p=0.017). Enterobacteriaceae spp. 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 cefuroxime group (p=0.03). Three neonates in the ampicillin group had proven ampicillin resistant EOS versus no EOS in the cefuroxime group. The proportion of primigravida 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))

Conclusion: In combination with roxithromycin, cefuroxime compared to ampicillin showed longer pregnancy and less maternal and neonatal morbidity, as a prophylactic for PPROM < 37

Primary Author(s)

Inshirah Sgayer, MD (she/her/hers)

Galilee Medical Center, Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel
Nahariya, HaZafon, Israel

Coauthor(s)

YN

Yara Nakhlah, MD

Galilee Medical Center
Nahariyya, HaZafon, Israel
DM

Dan Miron, MD

Department of Pediatrics A, Emek Medical Center, Afula, Israel Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel
Afula, HaZafon, Israel
ES

Elizabeta Shprits, MD

Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel
Haifa, HaZafon, Israel
VF

Vered Fleisher Sheffer, MD

Galilee Medical Center, Azrieli Faculty of Medicine, Bar Ilan University
Galilee Medical Center, HaZafon, Israel
HR

Hagai Rechnitzer, PhD

Clinical Microbiology Laboratory, Galilee Medical Center, Azrieli Faculty of Medicine, Bar Ilan University
Nahariyya, HaZafon, Israel
LL

Lior Lowenstein, MD

Galilee Medical Center
Nahariya, HaZafon, Israel

Presenting Author(s)

Maya Frank Wolf, MD

Galilee Medical Center, Azrieli Faculty of Medicine, Bar Ilan University, HaZafon, Israel

Slides