A Phase 4 interventional study of I.V cefuroxime 750 mg*3/d for 2 days and I.V ampicillin 2 gram x4/d for 2 days in Premature Rupture of Membrane, sponsored by Western Galilee Hospital-Nahariya. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by Western Galilee Hospital-Nahariya · Phase 4, Interventional, and Prevention
The objective of the study is to compare a new antibiotic protocol with the current prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm labor, chorioamnionitis and early onset sepsis
Preterm premature rupture of membranes (PPROM) occurs in approximately 3% of all pregnancies and is associated with approximately one-third of preterm births. The incidence of chorioamnionitis in women with premature rupture of membranes (PROM) at \< 27, 28 to 36, and > 37weeks' gestation is 41, 15, and 2%, respectively. Intra-amniotic infection is usually polymicrobial, comprised vaginal or enteric flora including aerobic and anaerobic bacteria and atypical agents, such as Mycoplasma. Group B streptococcus (GBS) has been a frequent pathogen. The American College of Obstetricians and Gynecologists approach to PPROM consists of recommending induction of labor in all women > 34 weeks' gestation. In the absence of intrauterine infection, placental abruption or non-reassuring fetal heart rate, management of women with PPROM \< 34 weeks consists of hospitalization from the time of diagnosis until delivery, administration of antenatal corticosteroids, and a 7-day course of antibiotic prophylactic therapy to prolong the latency period. Antibiotic therapy has been associated with significant reductions in chorioamnionitis, deliveries within 48 hours, and early-onset (within 3 days of delivery) neonatal sepsis (EOS). The antibiotic regimen in PPROM usually consists of ampicillin intravenously for 48 hours, followed by oral amoxicillin for 5 days (specifically targeting GBS), and a macrolide targeting atypical agents.
An increase in EOS due to gram negative Enterobacteriaceae have been reported lately with a relative decrease in GBS related EOS . These data may have an impact on the antibiotic regimen used for PPROM. The Local pathogens distribution in cases of EOS and their antibiotic sensitivity profiles in Northern Israel have been explored in a multicenter study There were 27 neonates diagnosed with EOS with positive blood cultures. Aerobic Enterobacteriaceae accounted for 14 cases (52%) and group B streptococcus for 7 cases (26%). Of the Escherichia coli and Klebsiella sp.,only 38% were sensitive to ampicillin. As a result the most effective antibiotic protocol to cover those pathogens is required. The purpose of the current study is to compare a new antibiotic protocol with the current prophylactic treatment in use and to evaluate pregnancy and neonatal outcome.
The diagnosis of preterm premature rupture of membranes (PPROM) is clinical, and is based on visualization of amniotic fluid in the vagina of a woman who presents with a history of leaking fluid. Laboratory tests as "Amniosure" can be used to confirm the clinical diagnosis when it is uncertain.
Women who meet the study criteria and have signed inform consent will be randomly divided in two groups to receive prophylactic antibiotic treatment as follow:
A course of corticosteroids will be given to all women participating in the study
Expectant management:
Labor induction will be conducted at 34 weeks of gestation If chorioamnionitis is suspected amniocentesis should be considered or expeditious delivery
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 400 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
I.V cefuroxime 750 mg\*3/d for 2days followed by P.O cefuroxime 500 mgx2/d in addition to P.O roxithromycin 150 mg\*2/d for 7 days
Drug: I.V cefuroxime 750 mg*3/d for 2 days · Drug: P.O cefuroxime 500 mgx2/d for 5 days · Drug: P.O roxithromycin 150 mg*2/d for 7 days
I.V ampicillin 2 gram x4/d for 2 days followed by P.O moxypen 500 mgx3/d for 5 days in addition to P.O roxithromycin 150 mg\*2/d for 7 days
Drug: I.V ampicillin 2 gram x4/d for 2 days · Drug: P.O roxithromycin 150 mg*2/d for 7 days · Drug: P.O moxypen 500 mgx3/d for 5 days
EARLY NEONATAL SEPSIS - positive blood culture
Number of Participants with early neonatal sepsis
Time frame: within 3 days of delivery
latency period
time in days
Time frame: from date of randomization until the date of delivery assessed up to 10 weeks
Chorioamnionitis rate
rate of positive cultures
Time frame: from day of randomization until date of clinical/laboratory chorioamnionitis diagnosis assessed up to 10 weeks
Neonatal weight
grams
Time frame: at delivery
Apgar score
score from 0 to 10
Time frame: 1 minute 5 minute
Number of participants with adverse events as assessed by umbilical cord acid-based analysis<7
cord ph analysis at delivery (units of moles per liter)
Time frame: at delivery
Neonatal intensive care unit (NICU) admission duration
days from admission until rerelease from NICU assessed up to 6 month
Time frame: days since delivery until rerelease from NICU, assessed up to 6 month
Plan to share: No
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Western Galilee Hospital-Nahariya