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

Phase 3

Completed

• Conditions: Preterm Premature Rupture of Membrane
• Interventions: Drug: Cefazolin; Drug: Clarithromycin

• Registration Number: NCT01503606
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-12-25
• Study First Submitted QC: 2012-01-01
• Study First Posted: 2012-01-04
• Primary Completion: 2020-12
• Study Completion: 2021-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one-week treatment group	Cefazolin	Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week
until-delivery treatment group	Cefazolin	Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery
until-delivery treatment group	Clarithromycin	Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery
one-week treatment group	Clarithromycin	Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week

Primary Outcome Measures

Name	Time	Method
Neonatal composite morbidity	Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks	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

Secondary Outcome Measures

Name	Time	Method
infantile neurologic outcome	at 6 months and 1 year of corrected age	The outcome will be 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

Trial Locations

Locations (1)

Samsung Medical center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of