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Analysis of ROM Plus to Detect Rupture of Membranes

This study has been completed.
Sponsor:
Collaborators:
Midwestern University
The Reading Hospital and Medical Center
University of Utah
Information provided by (Responsible Party):
Clinical Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01366443
First received: June 2, 2011
Last updated: July 30, 2012
Last verified: July 2012

June 2, 2011
July 30, 2012
September 2010
April 2012   (final data collection date for primary outcome measure)
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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.
Rupture of amniotic membranes [ Time Frame: one week ] [ Designated as safety issue: No ]
The time frame is from the presentation of leaking fluid in the vaginal vault until the patient delivers.
Complete list of historical versions of study NCT01366443 on ClinicalTrials.gov Archive Site
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Analysis of ROM Plus to Detect Rupture of Membranes
Analysis of ROM Plus to Detect Rupture of Membranes

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Rupture of Amniotic 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
women pregnant
Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Interventions:
  • Procedure: Sterile speculum exam
  • Procedure: ROM Plus Exam
  • Procedure: Chart Reveiw
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
April 2012
April 2012   (final data collection date for primary outcome measure)

Exclusion Criteria:

  • Known placental previa
  • Active vaginal bleeding
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01366443
ROM Plus Clinical Study
Yes
Clinical Innovations, LLC
Clinical Innovations, LLC
  • Midwestern University
  • The Reading Hospital and Medical Center
  • University of Utah
Not Provided
Clinical Innovations, LLC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP