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Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam

NCT00589329 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-04

Study results available
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Summary

Preterm birth remains a major health concern affecting up to 12% of all live births prior to 37 weeks gestation. As preterm birth can often be associated with infection our proposal is to evaluate in a randomized fashion antibiotics for women with advanced cervical exams.

Conditions

  • Length of Pregnancy Prolongation in Hours

Interventions

DRUG

erythromycin and metronidazole (antibiotics)

Erythromycin 250 mg IV q 6 hours x 8 doses, followed erythromycin 250 mg tabs, 1 PO q 8 hours for five days. Metronidazole, 1 gm IV loading dose followed by 500 mg IV q 12 hours x 4 doses, followed by metronidazole 500 mg tabs, 1 PO q 8 hours for five days

DRUG

placebo

IV and pill placebo

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Brian Mercer, M.D. · MetroHealth Medical Center MFM Director

  • Thaddeus Waters, M.D. · MetroHealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00589329 on ClinicalTrials.gov