Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Drug: oral penicillin V
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823433
|Contact: Evie Russell, RN||248-898-5388||Evie.Russell@beaumont.edu|
|Contact: John E Uckele, MD||John.Uckele@beaumont.edu|
|United States, Michigan|
|William Beaumont Hospital||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator: John E Uckele, MD|
|Principal Investigator:||John E Uckele, MD||William Beaumont Hospitals|