An Early Phase 1 interventional study of oral penicillin V in Group B Streptococcus, sponsored by Corewell Health East. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by Corewell Health East · Early Phase 1, Interventional, and Prevention
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.
Corewell Health East is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
2 grams of oral penicillin V given within 4 hours of delivery
Drug: oral penicillin V
2 grams of oral penicillin V given within 4 hours of delivery.
The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.
Time frame: after delivery
Compare levels of penicillin in the umbilical cord blood of women who received oral penicillin to the levels of women who received intravenous penicillin in labor. Comparisons will be done through literature only.
Time frame: after delivery
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Penicillin V
Corewell Health East