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Analysis of ROM Plus to Detect Rupture of Membranes

NCT01366443 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 288

Last updated 2012-07-31

Study results available
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Summary

Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.

Conditions

  • Rupture of Amniotic Membranes

Interventions

PROCEDURE

Sterile speculum exam

Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations

PROCEDURE

ROM Plus Exam

Vaginal swab exam for ROM Plus Test

PROCEDURE

Chart Reveiw

Post delivery blinded chart review by expereienced obstetrician

Sponsors & Collaborators

  • Midwestern University

    collaborator OTHER

  • The Reading Hospital and Medical Center

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Clinical Innovations, LLC

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01366443 on ClinicalTrials.gov