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Analysis of ROM Plus to Detect Rupture of Membranes

NCT ID: NCT01366443

Last Updated: 2012-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-04-30

Brief Summary

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Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.

Detailed Description

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This study is designed to assess the sensitivity and specificity of ROM PLUS- a rapid, point of care, qualitative immunochromatographic test for the detection (in vitro) of amniotic fluid in cervico-vaginal secretions of women with suspected rupture of membranes (ROM) during pregnancy. The ROM PLUS detects a specific Combo protein present in amniotic fluid of pregnant women in all trimesters of pregnancy. This specific protein combo is unique and found only in amniotic fluid, therefore can be used as a specific marker for the diagnosis of ROM. This biomarker is an isoform of a similar biomarkers called Amni-Sure and ActimProm and was recently approved by the FDA for clinical use. Like these protein markers ( AmniSure or ActimProm) which have been used to diagnose PROM, this particular protein isoform tested for ROM PLUS is in low concentration in other body fluids such as maternal blood, cord blood, urine and semen.

Conditions

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Rupture of Amniotic Membranes

Keywords

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ROM PLUS conventional clinical tests of rupture of membranes (ROM) speculum exam visualization of leakage pooling of amniotic fluid in the posterior fornix nitrazine testing ferning

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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women pregnant

Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Sterile speculum exam

Intervention Type PROCEDURE

Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations

ROM Plus Exam

Intervention Type PROCEDURE

Vaginal swab exam for ROM Plus Test

Chart Reveiw

Intervention Type PROCEDURE

Post delivery blinded chart review by expereienced obstetrician

Interventions

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Sterile speculum exam

Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations

Intervention Type PROCEDURE

ROM Plus Exam

Vaginal swab exam for ROM Plus Test

Intervention Type PROCEDURE

Chart Reveiw

Post delivery blinded chart review by expereienced obstetrician

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* Known placental previa
* Active vaginal bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Midwestern University

OTHER

Sponsor Role collaborator

The Reading Hospital and Medical Center

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

Clinical Innovations, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Lee SI, Park JS, Norwitz ER et al. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes, Obstet Gyencol 2007;109:634-40 Cousins, LM, Smok, P. Lovett, SM, Poeltler, DM. AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes. American J. of Perinatology. 2005;Vol.20:1-4. Caughey, AB., Robinson, JN., Norwitz, ER. Contemporary Diagnosis and Management of Preterm Premature Rupture of Membranes. Rev. Obstet. Gynecol. 2008;1(1):11-22.

Reference Type BACKGROUND

Other Identifiers

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ROM Plus Clinical Study

Identifier Type: -

Identifier Source: org_study_id