Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

Group B Streptococcus Clinical Trial

Official title:

Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823433
• Other study ID #: 2008-183
• Status: Terminated
• Phase: Phase 0
• First received: January 13, 2009
• Last updated: November 2, 2016
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Group B Streptococcus

Intervention

Drug:
• oral penicillin V
2 grams of oral penicillin V given within 4 hours of delivery.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.		after delivery	No
Secondary	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.		after delivery	No