Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Group B Streptococcus
Intervention: oral penicillin V (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: William Beaumont Hospitals Official(s) and/or principal investigator(s): John E Uckele, MD, Principal Investigator, Affiliation: William Beaumont Hospitals
Overall contact: Evie Russell, RN, Phone: 248-898-5388, Email: Evie.Russell@beaumont.edu
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.
Clinical Details
Official title: Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?
Study design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Evie Russell, RN, Phone: 248-898-5388, Email: Evie.Russell@beaumont.edu
William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting John E Uckele, MD, Principal Investigator
Additional Information
Starting date: January 2009
Last updated: November 6, 2012
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