Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
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|ClinicalTrials.gov Identifier: NCT00823433|
Recruitment Status : Terminated (Insufficient enrollment.)
First Posted : January 15, 2009
Last Update Posted : November 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Group B Streptococcus||Drug: oral penicillin V||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Oral Penicillin
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823433
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||John E Uckele, MD||William Beaumont Hospitals|