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Antibiotics Study in Preterm Premature Rupture of the Membranes (PPROM)

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ClinicalTrials.gov Identifier: NCT01401179
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE July 19, 2011
First Posted Date  ICMJE July 25, 2011
Last Update Posted Date August 8, 2011
Study Start Date  ICMJE April 2005
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
The number of participants with histologic acute chorioamnionitis and funisitis from their placental examination. [ Time Frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks. ]
Staging of inflammation of placenta was evaluated according to described as followings;
  1. Acute chorioamnionitis (maternal inflammatory response) was subdivided into 3 stages; Stage 1 as acute subchorionitis/acute chorionitis; Stage 2 as acute chorioamnionitis; Stage 3 as necrotizing chorioamnionitis.
  2. Acute funitis (fetal inflammatory response) was also subdivided as 3 stages: stage 1 as umbilical phlebitis/chorionic vasculitis; stage 2 as umbilical arteritis; stage 3 as necrotizing funisitis. Stage 0 was defined when no evidence of inflammation on histological examination of placenta.
Change History Complete list of historical versions of study NCT01401179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
  • the incidence of abnormal brain sonography [ Time Frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks. ]
  • infantile neurologic outcome [ Time Frame: at 6 months and 1 year of corrected age ]
    The outcome was 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotics Study in Preterm Premature Rupture of the Membranes
Official Title  ICMJE 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
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.
Detailed Description Despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. Although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. Antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. However the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. The group 1 is treated only with cefazolin (1.0mg iv every 6 hours for 7 days). The group 2 is given a combination of cefazolin(1.0mg iv every 6 hours for 7 days) and erythromycin(250mg p.o. four times a day for 7 days). In group 3, clarithromycin (500mg p.o. 4 times a day for 7 days) was treated with cefazolin(1.0mg iv every 6 hours for 7 days). This study is designed 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, especially by comparing the combination regimen in PPROM.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Preterm Premature Rupture of the Membranes
Intervention  ICMJE Drug: cefazolin, erythromycin, clarithromycin
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.
Study Arms  ICMJE
  • Active Comparator: cefazolin
    Intervention: Drug: cefazolin, erythromycin, clarithromycin
  • Active Comparator: cefazolin plus erythromycin
    cefazolin, erythromycin
    Intervention: Drug: cefazolin, erythromycin, clarithromycin
  • Active Comparator: cefazolin plus clarithromycin
    Intervention: Drug: cefazolin, erythromycin, clarithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2011)
101
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01401179
Other Study ID Numbers  ICMJE 2005-04-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soo-young Oh, M.D. PhD, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soo-Young Oh, M.D., PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP