Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

William Beaumont Hospitals

Status and phase: Terminated; Early Phase 1

Conditions: Group B Streptococcus

Treatments: Drug: oral penicillin V

Study type: Interventional

Funder types: Other

Identifiers

NCT00823433

2008-183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Oral Penicillin

Experimental group

Description:

2 grams of oral penicillin V given within 4 hours of delivery

Treatment:

Drug: oral penicillin V