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Completed

NCT Number: NCT01401179

Antibiotics Study in 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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cefazolin, erythromycin, clarithromycin

Drug

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.

Primary outcomes

  1. Neonatal composite morbidity

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

    • respiratory distress syndrome(RDS)
    • bronchopulmonary dysplasia(BPD)
    • intraventricular hemorrhage(IVH,≥grade 3)
    • retinopathy of prematurity(ROP,≥grade 3)
    • necrotizing enterocolitis(NEC,≥stage 2)
    • proven neonatal sepsis

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: PPROM

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 25, 2011
Registry last updated
Aug 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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