Group B Streptococcus | Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
Group B Streptococcus research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - pregnant women admitted for delivery or for induction of labor - singleton pregnancy - 18 years old or older - beyond 36 weeks gestation - able to comprehend study and give informed consent Exclusion Criteria: - known history of beta-lactam antibiotic allergy - impaired renal function - multiple gestation - current use of antibiotics - plan to bank cord blood after delivery
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Group B Streptococcus
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:oral penicillin V2 grams of oral penicillin V given within 4 hours of delivery.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Oral Penicillin2 grams of oral penicillin V given within 4 hours of delivery
Start Date: January 2009
Completed Date: December 2009
Phase: Early Phase 1
Primary Outcome: The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.
Secondary Outcome: 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.
Study sponsors, principal investigator, and references
Principal Investigator: John E Uckele, MD
Lead Sponsor: William Beaumont Hospitals