Efficacy Study of Rapid Immunoassay Diagnostic Test Utilizing PP12 and AFP, ROM Plus

Status unconfirmed

Conditions studied: PROM

In brief

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.

Key facts

Study ID

NCT02524691

Run by

Clinical Innovations, LLC

People needed

324

Starts

2015-08-01

Expected to finish

2016-10-01

Last updated by the study team

2016-08-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Christiana Care Health Services — Newark, Delaware, United States
• Cooper Health System — Camden, New Jersey, United States
• Intermountain Healthcare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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