A Phase 3 interventional study of cefazolin, erythromycin, clarithromycin in Preterm Premature Rupture of the Membranes, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants. Per ClinicalTrials.gov, last updated 2011-08-08.
Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in PPROM.
Despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. Although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. Antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. However the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. The group 1 is treated only with cefazolin (1.0mg iv every 6 hours for 7 days). The group 2 is given a combination of cefazolin(1.0mg iv every 6 hours for 7 days) and erythromycin(250mg p.o. four times a day for 7 days). In group 3, clarithromycin (500mg p.o. 4 times a day for 7 days) was treated with cefazolin(1.0mg iv every 6 hours for 7 days). This study is designed to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality and to review the evidence and provide recommendations on the use of antibiotics, especially by comparing the combination regimen in PPROM.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 101 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Drug: cefazolin, erythromycin, clarithromycin
cefazolin, erythromycin
Drug: cefazolin, erythromycin, clarithromycin
Drug: cefazolin, erythromycin, clarithromycin
Antibiotics regimen was one of cefazolin or cefazolin plus erythromycin or cefazolin plus clarithromycin. Intravenous 1g cefazolin was given every 6 hours after negative result skin test for allergic reaction. With cefazolin plus erythromycin group or cefazolin plus clarithromycin, cefazolin was given with same protocol and 250mg oral erythromycin every 6 hours or 500mg oral clarithromycin every 12 hours was added. All antibiotics were given for 7 days or until delivery.
Neonatal composite morbidity
1. respiratory distress syndrome(RDS) 2. bronchopulmonary dysplasia(BPD) 3. intraventricular hemorrhage(IVH,≥grade 3) 4. retinopathy of prematurity(ROP,≥grade 3) 5. necrotizing enterocolitis(NEC,≥stage 2) 6. proven neonatal sepsis
Time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
the incidence of abnormal brain sonography
Time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
infantile neurologic outcome
The outcome was evaluated in five sub-domains (development, neurologic examination, Bayley Scales of Infant Development-II, vision, and hearing). The final outcome scale was divided into normal, mild, moderate, and severe disability.
Time frame: at 6 months and 1 year of corrected age
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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