Group B Streptococcus Clinical Trial
Official title:
Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?
Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical cord. These cord blood samples will be sent for bioassay of penicillin levels.
According to the CDC, before screening for GBS colonization was implemented, early onset GBS
disease occurred at a rate of 1.5-2 per 1,000 live births. Antibiotic treatment for GBS
colonized women according to guideline recommended by the American College of Obstetricians
and Gynecologists (ACOG) decreases the risk for early onset neonatal GBS infection 10 fold.
Unfortunately, many eligible women don't receive the full treatment protocol. Although the
rate of early onset infection is low, the newborns of group B strep positive women who do
not receive the recommended preventative antibiotics must undergo testing and extended
observation.
This study will determine the level of antibiotics in the umbilical vein cord blood of
newborn infants after the administration of penicillin orally while in labor and compare
these levels to levels of penicillin in the umbilical vein cord blood of patients treated
with intravenous penicillin in labor. Comparisons will be done through literature only;
there will be no intravenous penicillin administration arm of the study.
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Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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