Antibiotics for pPROM

to prolong pregnancy and reduce infection

Prevention
Prevention
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Antibiotics for pPROM
    Generic erythromycin tablets

    Global annual deaths associated with infections and prematurity

    PERCENT (%)
    NUMBER

    Maternal

    20%
    51,000

    Neonatal

    65%
    2,000,000

    Stillbirth

    N/A
    N/A

    Condition
    Pre-term, premature rupture of membranes (pPROM) occurs when the amniotic sac ruptures before 37 weeks of gestation and prior to the onset of labor. It is a common cause of pre-term birth and is present in about one third of cases in high-resource settings. Maternal and neonatal infection is highly correlated with pPROM. The putative mechanism is that ascending bacteria from the genital tract trigger an inflammatory response in the decidua and fetal membranes. This triggers the release of prostaglandins and other substances that soften the cervix and initiate contractions leading to membrane rupture and preterm delivery. Preterm infants have markedly higher morbidity and mortality rates.

    Mechanism of Action
    Antibiotics may help in two ways. First, they treat the maternal/ neonatal infection, thereby reducing infection-related morbidity. Second, by stopping the ascending bacteria, antibiotics may prolong pregnancy, allowing the fetus to further mature. The benefit of antibiotics is greatest following pPROM at less than 32 weeks gestation. Ampicillin, amoxicillin, and erythromycin are all commonly used, either in an IV phase followed by an oral phase, or using an oral phase alone.

    Current use in High-Resource Settings
    Using an IV phase followed by an oral phase, caregivers often prescribe 2g ampicillin and 250mg erythromycin IV every 6 hours for 48 hours, followed by 250mg amoxicillin and 333mg erythromycin every 8 hours for 5 days. Using an oral only program, caregivers often prescribe 250mg orally every 6 hours for 10 days. Systematic review of existing randomized controlled studies does not suggest that oral only regimes are less effective.

     

    Application in Low-Resource Settings
    Antibiotics for pPROM are used infrequently in low-resource settings. Even in the absence of other interventions, including antenatal steroids, surfactant, and ventilation, experts estimate that increasing use of antibiotics for pPROM from 0% to 100% could “prevent 4% of neonatal deaths due to complications of prematurity and 8% of those due to infection.” At approximately $0.84 for the full ten day oral course, this may represent an especially cost effective way to save lives.

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE
    TECH
    STATUS
    NOTES

    Generic

    Ampicillin
    $0.15
    2g for IV
    Marketed
    Refrigeration after reconstitution

    Generic

    Erythromycin
    $0.37
    250mg for IV
    Marketed
    Refrigeration after reconstitution

    Generic

    Erythromycin
    $0.02
    250mg tab
    Marketed
    Widely available, inexpensive

    Generic

    Amoxicillin
    $0.01
    250mg tab
    Marketed
    Widely available, inexpensive

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Mother, nurse
    Minutes
    Seconds per dose

    A patient aid documenting the correct use of the drug could be helpful, but not required.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    None
    Clock
    Room temperature
    None

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    <$0.10/tablet
    40 tablets over 10 days total ~$1.00

    OTHER

    Portability
    Regulatory
    Efficacy
    <50g
    Approved
    Meta-analysis of 15 studies of 4265 newborns suggests a neonatal mortality risk ratio of 0.90

    Additional technology required for impact: Lives saved will rise with the availability of other technologies used for complications of prematurity.

Sources: S Cousens et al. Antibiotics for pre-term pre-labour rupture of membranes: prevention of neonatal deaths due to complications of pre-term birth and infection. Int J Epidemiol. 2010 April; 39(suppl_1): i134–i143. Society of Obstetricians and Gynaecologists of Canada. SOGC Clinical Practice Guideline. Antibiotic Therapy in Preterm Premature Rupture of the Membranes. JOGC. September 2009. Management Sciences for Health (MSH). International Drug Price Indicator Guide 2009