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

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503606

Enrollment

151

Registered

2012-01-04

Start date

2011-10-31

Completion date

2021-12-31

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Premature Rupture of Membrane

Keywords

preterm premature rupture of membrane, antibiotics, duration, cefazolin, clarithromycin

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.

Interventions

DRUGCefazolin

Cefazolin 1.0gm IVs q 12 hours after randomization for one week

DRUGClarithromycin

clarithromycin 500mg po bid after randomization for one week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026