Clinical Evaluation of the AmniSure ROM Test

July 12, 2016 updated by: QIAGEN Gaithersburg, Inc
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.

Study Type

Observational

Enrollment (Actual)

383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93701
        • University of California San Francisco- Fresno
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center Research Institute, Inc
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation.

Description

Inclusion Criteria:

  • Subjects must be pregnant.
  • Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks.
  • Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM.
  • Subjects providing informed consent.

Exclusion Criteria:

  • Subjects who have placenta previa.
  • Subjects who have heavy vaginal bleeding.
  • Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic
Individuals with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation that will receive the AmniSure ROM test.
Device: AmniSure ROM test
Comparison of AmniSure ROM test to clinical diagnosis of ROM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
Time Frame: One time at time of enrollment
The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes.
One time at time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QIAGEN Gaithersburg, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C13-ROM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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