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Analysis of ROM Plus to Detect Rupture of Membranes

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ClinicalTrials.gov Identifier: NCT01366443
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Rupture of Amniotic Membranes Procedure: Sterile speculum exam Procedure: ROM Plus Exam Procedure: Chart Reveiw

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 288 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of ROM Plus to Detect Rupture of Membranes
Study Start Date : September 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
women pregnant
Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Procedure: Sterile speculum exam
Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
Procedure: ROM Plus Exam
Vaginal swab exam for ROM Plus Test
Procedure: Chart Reveiw
Post delivery blinded chart review by expereienced obstetrician

Outcome Measures

Primary Outcome Measures :
  1. Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus [ Time Frame: 1 week ]
    Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Exclusion Criteria:

  • Known placental previa
  • Active vaginal bleeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366443

United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 894132
Sponsors and Collaborators
Clinical Innovations, LLC
Midwestern University
The Reading Hospital and Medical Center
University of Utah
More Information

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.

Responsible Party: Clinical Innovations, LLC
ClinicalTrials.gov Identifier: NCT01366443     History of Changes
Other Study ID Numbers: ROM Plus Clinical Study
First Posted: June 6, 2011    Key Record Dates
Results First Posted: July 31, 2012
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Clinical Innovations, LLC:
conventional clinical tests of rupture of membranes (ROM)
speculum exam
visualization of leakage
pooling of amniotic fluid in the posterior fornix
nitrazine testing

Additional relevant MeSH terms:
Wounds and Injuries