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Analysis of ROM Plus to Detect Rupture of Membranes

This study has been completed.
Midwestern University
The Reading Hospital and Medical Center
University of Utah
Information provided by (Responsible Party):
Clinical Innovations, LLC Identifier:
First received: June 2, 2011
Last updated: July 30, 2012
Last verified: July 2012
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 Intervention
Rupture of Amniotic Membranes
Procedure: Sterile speculum exam
Procedure: ROM Plus Exam
Procedure: Chart Reveiw

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of ROM Plus to Detect Rupture of Membranes

Resource links provided by NLM:

Further study details as provided by Clinical Innovations, LLC:

Primary Outcome Measures:
  • 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.

Enrollment: 288
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

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
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Please refer to this study by its identifier: 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 Identifier: NCT01366443     History of Changes
Other Study ID Numbers: ROM Plus Clinical Study
Study First Received: June 2, 2011
Results First Received: April 26, 2012
Last Updated: July 30, 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 processed this record on May 25, 2017