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| Sponsor: | William Beaumont Hospitals |
|---|---|
| Information provided by: | William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00823433 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Group B Streptococcus |
Drug: oral penicillin V |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Active Control, Single Group Assignment, Bio-availability Study |
| Official Title: | Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients? |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Evie Russell, RN | 248-898-5388 | Evie.Russell@beaumont.edu |
| Contact: Brendon Conboy, MD | 248-992-0286 | Brendan.Conboy@beaumont.edu |
| United States, Michigan | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Principal Investigator: Brendan Conboy, MD | |
| Principal Investigator: | Brendan Conboy, MD | William Beaumont Hospitals |
More Information
| Responsible Party: | William Beaumont Hospital ( Brendan Conboy, MD ) |
| Study ID Numbers: | 2008-183 |
| Study First Received: | January 13, 2009 |
| Last Updated: | December 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00823433 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Penicillin Group B Streptococcus Pregnancy Labor |
|
Anti-Infective Agents Anti-Bacterial Agents Penicillin V Therapeutic Uses Pharmacologic Actions |