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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-week treatment group | Active Comparator | Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week |
|
| until-delivery treatment group | Active Comparator | Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin | Drug | Cefazolin 1.0gm IVs q 12 hours after randomization for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal composite morbidity |
| Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-young Oh, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical center, Sungkyunkwan University School of Medicine | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746334 | Derived | Sung JH, Kim JH, Kim Y, Choi YS, Hong S, Choi SJ, Kim JS, Roh CR, Oh SY. A randomized clinical trial of antibiotic treatment duration in preterm pre-labor rupture of membranes: 7 days vs until delivery. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100886. doi: 10.1016/j.ajogmf.2023.100886. Epub 2023 Feb 4. |
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| Clarithromycin | Drug | clarithromycin 500mg po bid after randomization for one week |
|
| Cefazolin | Drug | Cefazolin 1.0gm IVs q 12 hours after randomization until delivery |
|
| Clarithromycin | Drug | clarithromycin 500mg po bid after randomization until delivery |
|
| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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