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Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by William Beaumont Hospitals.
Recruitment status was  Recruiting
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
History of Changes
  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: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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:

U.S. FDA Resources

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 2013
Estimated Primary Completion Date: June 2013 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823433

Contacts
Contact: Evie Russell, RN 248-898-5388 Evie.Russell@beaumont.edu
Contact: John E Uckele, MD John.Uckele@beaumont.edu

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

Responsible Party: John Uckele, Attending Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00823433     History of Changes
Other Study ID Numbers: 2008-183 
Study First Received: January 13, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Penicillins
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 29, 2016