NCT00823433

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

January 13, 2009

Last Update Submit

November 2, 2016

Conditions

Group B Streptococcus

Keywords

PenicillinGroup B StreptococcusPregnancyLabor

Outcome Measures

Primary Outcomes (1)

  • The level of antibiotics in the umbilical vein cord blood of newborn infants after the administration of penicillin orally while in labor.

    after delivery

Secondary Outcomes (1)

  • 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

Study Arms (1)

Oral Penicillin

EXPERIMENTAL

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

Drug: oral penicillin V

Interventions

oral penicillin VDRUG

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

Oral Penicillin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women admitted for delivery or for induction of labor
  • singleton pregnancy
  • years old or older
  • beyond 36 weeks gestation
  • able to comprehend study and give informed consent

You may not qualify if:

  • known history of beta-lactam antibiotic allergy
  • impaired renal function
  • multiple gestation
  • current use of antibiotics
  • plan to bank cord blood after delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Interventions

Penicillin V

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • John E Uckele, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

US(1)