Antibiotics Study in Preterm Premature Rupture of the Membranes

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin; Clarithromycin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Criteria

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)