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PROMComplete for Determination of Rupture of Fetal Membranes

NCT02369601 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2018-04-25

No results posted yet for this study

Summary

Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased incidence of perinatal mortality and intra-amniotic infection. There is a need for improved diagnostic testing because of limitations of the current methods.

PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.

Conditions

  • Fetal Membranes, Premature Rupture

Interventions

OTHER

non- intervention study

Study design is non-interventional. Patient therapy will not be affected by study participation.

Sponsors & Collaborators

  • Pro-Lab Diagnostics

    lead INDUSTRY

Principal Investigators

  • Andrew Rae · Pro-Lab Diagnostic VP

  • Hector Chapa, M.D. · Methodist Medical Center Dallas

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-12-31
Completion
2018-12-31

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 NCT02369601 on ClinicalTrials.gov