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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Oh Soo Young, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01503606
First received: December 25, 2011
Last updated: January 1, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Preterm Premature Rupture of Membrane
Drug: Cefazolin
Drug: Clarithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Neonatal composite morbidity [ Time Frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks ] [ Designated as safety issue: No ]
    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:
  • infantile neurologic outcome [ Time Frame: at 6 months and 1 year of corrected age ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 206
Study Start Date: October 2011
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oh Soo Young, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01503606     History of Changes
Other Study ID Numbers: 2011-07-005
Study First Received: December 25, 2011
Last Updated: January 1, 2012
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Obstetric Labor Complications
Rupture
Fetal Membranes, Premature Rupture
Wounds and Injuries
Pregnancy Complications
Anti-Bacterial Agents
Clarithromycin
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014