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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01401179
First received: July 19, 2011
Last updated: August 5, 2011
Last verified: July 2011

July 19, 2011
August 5, 2011
April 2005
April 2010   (final data collection date for primary outcome measure)
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
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. ] [ Designated as safety issue: No ]

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.
Complete list of historical versions of study NCT01401179 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • infantile neurologic outcome [ Time Frame: at 6 months and 1 year of corrected age ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Antibiotics Study in Preterm Premature Rupture of the Membranes
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Preterm Premature Rupture of the Membranes
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
April 2010
April 2010   (final data collection date for primary outcome measure)

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)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01401179
2005-04-003
Yes
Soo-young Oh, M.D. PhD, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center
Not Provided
Principal Investigator: Soo-Young Oh, M.D., PhD Samsung Medical Center
Samsung Medical Center
July 2011

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