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Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

This study has been terminated.
(Insufficient enrollment.)
Sponsor:
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00823433
First received: January 13, 2009
Last updated: November 2, 2016
Last verified: November 2016
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 Early Phase 1

Study Type: Interventional
Study Design: 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 John Uckele, 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 ]

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 ]
Enrollment: 25
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Penicillin
2 grams of oral penicillin V given within 4 hours of delivery
 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)
Sexes 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

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
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 2, 2016

Keywords provided by John Uckele, 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 July 28, 2017