NCT01401179

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

August 8, 2011

Status Verified

July 1, 2011

Enrollment Period

5 years

First QC Date

July 19, 2011

Last Update Submit

August 5, 2011

Conditions

Preterm Premature Rupture of the Membranes

Keywords

Preterm Premature Rupture of Fetal Membranesantibiotic therapy

Outcome Measures

Primary Outcomes (1)

  • Neonatal composite morbidity

    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

    Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.

Secondary Outcomes (2)

  • the incidence of abnormal brain sonography

    Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.

  • infantile neurologic outcome

    at 6 months and 1 year of corrected age

Study Arms (3)

cefazolin

ACTIVE COMPARATOR
Drug: cefazolin, erythromycin, clarithromycin

cefazolin plus erythromycin

ACTIVE COMPARATOR

cefazolin, erythromycin

Drug: cefazolin, erythromycin, clarithromycin

cefazolin plus clarithromycin

ACTIVE COMPARATOR
Drug: cefazolin, erythromycin, clarithromycin

Interventions

cefazolin, erythromycin, clarithromycinDRUG

Antibiotics regimen was one of cefazolin or cefazolin plus erythromycin or cefazolin plus clarithromycin. Intravenous 1g cefazolin was given every 6 hours after negative result skin test for allergic reaction. With cefazolin plus erythromycin group or cefazolin plus clarithromycin, cefazolin was given with same protocol and 250mg oral erythromycin every 6 hours or 500mg oral clarithromycin every 12 hours was added. All antibiotics were given for 7 days or until delivery.

cefazolincefazolin plus clarithromycincefazolin plus erythromycin

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PPROM, PA 23+0\~33+0wks
  • ROM \<48 hrs before randomization
  • singleton
  • Cervical dilatation \<3cm
  • uterine contraction less than 4 times per 1 hr

You may not qualify if:

  • Major fetal malformation
  • Multifetal pregnancy
  • Rupture of the membrane \>8hrs before randomization
  • Prior antibiotics use at local clinic before referral
  • Vaginal bleeding
  • IIOC (incompetent internal os of cervix)
  • Placenta previa
  • Gestational diabetes or overt diabetes
  • Hypertensive disorders in pregnancy
  • Liver cirrhosis
  • Acute renal failure
  • IUGR(Intrauterine growth restriction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the MembranesFetal Membranes, Premature Rupture

Interventions

CefazolinErythromycinClarithromycin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesPolyketidesLactones

Study Officials

  • Soo-Young Oh, M.D., PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 25, 2011

Study Start

April 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 8, 2011

Record last verified: 2011-07

Locations

KR(1)