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

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ClinicalTrials.gov Identifier: NCT01503606
Recruitment Status : Unknown
Verified November 2015 by Oh Soo Young, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : January 4, 2012
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Preterm Premature Rupture of Membrane Drug: Cefazolin Drug: Clarithromycin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.
Study Start Date : October 2011
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: one-week treatment group
Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week
Drug: Cefazolin
Cefazolin 1.0gm IVs q 12 hours after randomization for one week
Drug: Clarithromycin
clarithromycin 500mg po bid after randomization for one week
Active Comparator: until-delivery treatment group
Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery
Drug: Cefazolin
Cefazolin 1.0gm IVs q 12 hours after randomization until delivery
Drug: Clarithromycin
clarithromycin 500mg po bid after randomization until delivery


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. infantile neurologic outcome [ Time Frame: 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503606


Contacts
Contact: Soo-Young Oh, M.D., PhD 82-2-3410-3517 ohsymd@skku.edu

Locations
Korea, Republic of
Samsung Medical center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Soo-young Oh, MD, PhD    82-2-3410-3519    ohsymd@skku.edu   
Principal Investigator: Soo-young Oh, MD,PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Soo-young Oh, MD, PhD Samsung Medical Center, Sungkyunkwan University School of Medicine
More Information

Responsible Party: Oh Soo Young, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01503606     History of Changes
Other Study ID Numbers: 2011-07-005
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Oh Soo Young, Samsung Medical Center:
preterm premature rupture of membrane
antibiotics
duration
cefazolin
clarithromycin

Additional relevant MeSH terms:
Premature Birth
Rupture
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Anti-Bacterial Agents
Clarithromycin
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors