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NCT01401179: PPROM
Randomized Phase III Trial of Cefazolin or Combination of Cefazolin and Erythromycin or Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of the Membranes
Phase 3 trial testing cefazolin, erythromycin, clarithromycin in Preterm Premature Rupture of the Membranes in 101 participants. Completed in 1 April 2010.
1 April 2010
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 1 April 2005 |
| Primary completion | 1 April 2010 |
| Estimated completion | 1 April 2010 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- cefazolin, erythromycin, clarithromycin — full drug profile →
Conditions studied
- Preterm Premature Rupture of the Membranes — all drugs for Preterm Premature Rupture of the Membranes →
Sponsor
Samsung Medical Center
Who can join
Eligibility, female only, with Preterm Premature Rupture of the Membranes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Neonatal composite morbidity
Time frame: 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
Sponsor's own description
The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in PPROM.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01401179
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01401179 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
- Last refreshed: 5 August 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01401179.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing