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

Study Overview
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Brief Summary
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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.

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

Conditions
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Preterm Premature Rupture of Membrane

Intervention / Treatment
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* Drug: Cefazolin
* Drug: Clarithromycin
* Drug: Cefazolin
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: one-week treatment group<br>Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week | Drug: Cefazolin<br>* Cefazolin 1.0gm IVs q 12 hours after randomization for one week<br>Drug: Clarithromycin<br>* clarithromycin 500mg po bid after randomization for one week<br>|
| Active Comparator: until-delivery treatment group<br>Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery | Drug: Cefazolin<br>* Cefazolin 1.0gm IVs q 12 hours after randomization until delivery<br>Drug: Clarithromycin<br>* clarithromycin 500mg po bid after randomization until delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal composite morbidity | respiratory distress syndrome(RDS) bronchopulmonary dysplasia(BPD) intraventricular hemorrhage(IVH,≥grade 3) retinopathy of prematurity(ROP,≥grade 3) necrotizing enterocolitis(NEC,≥stage 2) proven neonatal sepsis | Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infantile neurologic outcome | 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 | at 6 months and 1 year of corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm premature rupture of membrane, antibiotics, duration, cefazolin, clarithromycin