Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

This study is currently recruiting participants.
Verified November 2012 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00823433
First received: January 13, 2009
Last updated: November 6, 2012
Last verified: November 2012

January 13, 2009
November 6, 2012
January 2009
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00823433 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?

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.

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.

Interventional
Phase 0
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Group B Streptococcus
Drug: oral penicillin V
2 grams of oral penicillin V given within 4 hours of delivery.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact: Evie Russell, RN 248-898-5388 Evie.Russell@beaumont.edu
Contact: John E Uckele, MD John.Uckele@beaumont.edu
United States
 
NCT00823433
2008-183
Yes
John Uckele, William Beaumont Hospitals
William Beaumont Hospitals
Not Provided
Principal Investigator: John E Uckele, MD William Beaumont Hospitals
William Beaumont Hospitals
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP