Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
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| First Received Date ICMJE | January 13, 2009 | ||||||||
| Last Updated Date | November 6, 2012 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00823433 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood | ||||||||
| Official Title ICMJE | Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients? | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 0 | ||||||||
| Study Design ICMJE | Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Group B Streptococcus | ||||||||
| Intervention ICMJE | Drug: oral penicillin V
2 grams of oral penicillin V given within 4 hours of delivery. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00823433 | ||||||||
| Other Study ID Numbers ICMJE | 2008-183 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | John Uckele, William Beaumont Hospitals | ||||||||
| Study Sponsor ICMJE | William Beaumont Hospitals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | William Beaumont Hospitals | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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