Antibiotics Study in Preterm Premature Rupture of the Membranes (PPROM)

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Preterm Premature Rupture of the Membranes

Treatments: Drug: cefazolin, erythromycin, clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01401179

2005-04-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 101 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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101 participants in 3 patient groups

cefazolin

Active Comparator group

Treatment:

Drug: cefazolin, erythromycin, clarithromycin

cefazolin plus erythromycin

Active Comparator group

Description:

cefazolin, erythromycin

Treatment:

Drug: cefazolin, erythromycin, clarithromycin

cefazolin plus clarithromycin

Active Comparator group

Treatment:

Drug: cefazolin, erythromycin, clarithromycin