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Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood

NCT ID: NCT00823433

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Group B Streptococcus

Keywords

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Penicillin Group B Streptococcus Pregnancy Labor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oral Penicillin

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

Group Type EXPERIMENTAL

oral penicillin V

Intervention Type DRUG

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

Interventions

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oral penicillin V

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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John Uckele

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John E Uckele, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2008-183

Identifier Type: -

Identifier Source: org_study_id