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Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
This study is currently recruiting participants.
Verified by William Beaumont Hospitals, December 2009
First Received: January 13, 2009   Last Updated: December 9, 2009   History of Changes
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?

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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)
Intervention Details:
    Drug: oral penicillin V
    2 grams of oral penicillin V given within 4 hours of delivery.
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823433

Contacts
Contact: Evie Russell, RN 248-898-5388 Evie.Russell@beaumont.edu
Contact: Brendon Conboy, MD 248-992-0286 Brendan.Conboy@beaumont.edu

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Principal Investigator: Brendan Conboy, MD            
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Brendan Conboy, MD William Beaumont Hospitals
  More Information

No publications provided

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

Keywords provided by William Beaumont Hospitals:
Penicillin
Group B Streptococcus
Pregnancy
Labor

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Penicillin V
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010