Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane
Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Premature Rupture of Membrane
Intervention: Cefazolin (Drug); Clarithromycin (Drug); Cefazolin (Drug); Clarithromycin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s): Soo-young Oh, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
Overall contact: Soo-Young Oh, M.D., PhD, Phone: 82-2-3410-3517, Email: ohsymd@skku.edu
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.
Clinical Details
Official title: Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Neonatal composite morbidity
Secondary outcome: infantile neurologic outcome
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Soo-Young Oh, M.D., PhD, Phone: 82-2-3410-3517, Email: ohsymd@skku.edu
Samsung Medical center, Sungkyunkwan University School of Medicine, Seoul 135-710, Korea, Republic of; Recruiting Soo-young Oh, MD, PhD, Phone: 82-2-3410-3519, Email: ohsymd@skku.edu Soo-young Oh, MD,PhD, Principal Investigator
Additional Information
Starting date: October 2011
Last updated: January 1, 2012
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