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Rapid Immunoassay Tests for the Detection of Ruptured Membranes

NCT02495441 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-08-07

No results posted yet for this study

Summary

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.

Conditions

  • Premature Rupture of Membranes

Interventions

OTHER

Use of Rapid Immunoassay Tests for the Detection of PROM

After informed consent , both the ROM Plus®, ActimProm Amnioquick® Complete and AmniSure® bedside tests (without the use of a speculum) will be performed. The patient will then undergo the standard clinical assessment, which includes a sterile speculum exam (SSE). If either 1) amniotic fluid is seen leaking from the cervical os, or 2) if at least two of the following three clinical signs are present: visual pooling of fluid in the posterior fornix, positive nitrazine test, and microscopic evidence of ferning, then the patient will be considered positive for ROM. 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 IGFBP-1/AFP tests and Amnisure®.

Sponsors & Collaborators

  • Clinical Innovations, LLC

    collaborator INDUSTRY

  • De Soysa Hospital for Women

    lead OTHER

Principal Investigators

  • Hemantha Senanayake, MS, FRCOG · Department of Obstetrics & Gynaecology Faculty of Medicine University of Colombo, Sri Lanka

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-12-31
Completion
2016-08-31

Countries

  • Sri Lanka

Study Locations

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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 NCT02495441 on ClinicalTrials.gov