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Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women

NCT03715530 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-10-03

Study results available
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Summary

The study is to evaluate the accuracy of a test device called "PAMG-1" to see if a pregnant women has ruptured membranes in comparison to standardly used testing methods.

Conditions

Interventions

DEVICE

PAMG-1 immunoassay

The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip.

Sponsors & Collaborators

  • AmniSure International LLC

    collaborator OTHER

  • Mark Santillan

    lead OTHER

Principal Investigators

  • Mark Santillan, MD, PhD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-07-31
Completion
2011-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03715530 on ClinicalTrials.gov