Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Preterm Premature Rupture of Membrane

Treatments: Drug: Clarithromycin; Drug: Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT01503606

2011-07-005

Details and patient eligibility

About

The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.

Enrollment: 151 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm premature rupture of membrane(PPROM), PA 22+0~34+0wks
• ROM <72 hrs before randomization
• cervical dilatation <3cm
• uterine contraction less than 4 times per 1 hr

Exclusion criteria

• Major fetal malformation
• Rupture of the membrane >72hrs before randomization
• Vaginal bleeding
• IIOC (incompetent internal os of cervix)
• Placenta previa
• Gestational diabetes or overt diabetes
• Hypertensive disorders in pregnancy
• Liver cirrhosis
• Acute renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

one-week treatment group

Active Comparator group

Description:

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week

Treatment:

Drug: Cefazolin

Drug: Clarithromycin

Drug: Cefazolin

Drug: Clarithromycin

until-delivery treatment group

Active Comparator group

Description:

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery

Treatment:

Drug: Cefazolin

Drug: Clarithromycin

Drug: Cefazolin

Drug: Clarithromycin