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A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

NCT02208011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2020-09-02

No results posted yet for this study

Summary

Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.

Inclusion Criteria:

* English speaking
* pregnant woman \>15 weeks gestation undergoing an exam for ruptured membranes

Exclusion Criteria:

* Known placental previa
* Active vaginal bleeding

Conditions

  • Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

Sponsors & Collaborators

  • Woman's Hospital, Louisiana

    collaborator OTHER

  • Clinical Innovations, LLC

    collaborator INDUSTRY

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • Louisiana State University, Baton Rouge

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

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 NCT02208011 on ClinicalTrials.gov