Efficacy Study of Rapid Immunoassay Diagnostic Test Utilizing PP12 and AFP, ROM Plus
1 other identifier
observational
324
1 country
3
Brief Summary
The study is designed to establish the level of agreement between the ROM Plus test and the diagnosis of ROM as defined by the patient's clinical course, with respect to a population of pregnant women who present to the clinical site with signs and symptoms suggestive of ROM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
3 active sites
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
First Submitted
Initial submission to the registry
July 31, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedAugust 9, 2016
August 1, 2016
9 months
July 31, 2015
August 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The level of agreement between the ROM Plus test and the diagnosis of ROM as defined by the patient's clinical course, with respect to a population of pregnant women who present to the clinical site with signs and symptoms suggestive of ROM
3 months
Secondary Outcomes (1)
Number of tests results from the ROM Plus test that provide the same result as the Amnisure test
3 months
Interventions
Patient will undergo both rapid immunoassay tests for the detection of PROM and the standard of care for the diagnosis of PROM using a sterile speculum (SSE). Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of rapid immunoassay tests. The provider conducting the SSE will be blinded to the results of the rapid immunoassay tests.
Eligibility Criteria
Pregnant women undergoing an evaluation for suspected ROM.
You may qualify if:
- Pregnant women \>15 weeks gestation undergoing an evaluation for suspected ROM, as indicated by standard site procedures (multiple gestations will not be excluded).
- Patients (or their legal representatives) who are willing to voluntarily agree to sign a consent form.
You may not qualify if:
- Known placental previa
- Active vaginal bleeding (≥ menstrual period)
- Individuals \< 18 years of age.
- Patients (or their legal representatives) who are unwilling to voluntarily agree to sign a consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Christiana Care Health Services
Newark, Delaware, 19713, United States
Cooper Health System
Camden, New Jersey, 08103, United States
Intermountain Healthcare
Salt Lake City, Utah, 84123, United States
Study Officials
- STUDY CHAIR
Ross W McQuivey, MD
Clinical Innovations, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2015
First Posted
August 17, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2016
Study Completion
October 1, 2016
Last Updated
August 9, 2016
Record last verified: 2016-08