Antibiotics Study in Preterm Premature Rupture of the Membranes

Samsung Medical Center101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

101

Conditions

Preterm Premature Rupture of the Membranes

Interventions

cefazolin, erythromycin, clarithromycinDRUG

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * PPROM, PA 23+0\~33+0wks * ROM \<48 hrs before randomization * singleton * Cervical dilatation \<3cm * uterine contraction less than 4 times per 1 hr Exclusion Criteria: * Major fetal malformation * Multifetal pregnancy * Rupture of the membrane \>8hrs before randomization * Prior antibiotics use at local clinic before referral * Vaginal bleeding * IIOC (incompetent internal os of cervix) * Placenta previa * Gestational diabetes or overt diabetes * Hypertensive disorders in pregnancy * Liver cirrhosis * Acute renal failure * IUGR(Intrauterine growth restriction)

Locations (1)

Samsung Medical center

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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