Clinical trial NCT00823433: Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
Official title: Does Oral Penicillin Reach and Simulate Intravenous Penicillin Levels in Venous Umbilical Cord Blood of Laboring Pregnant Patients?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Group B Streptococcus
Keywords: Penicillin
Group B Streptococcus
Pregnancy
Labor
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.
timeFrame: after delivery
Secondary outcomes:
measure: 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.
timeFrame: after delivery
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: John E Uckele, MD
role: PRINCIPAL_INVESTIGATOR
References: