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
  Purpose

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

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 ] [ 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.

Criteria

Exclusion Criteria:

  • Known placental previa
  • Active vaginal bleeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366443

Locations
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

No publications provided

Responsible Party: Clinical Innovations, LLC
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Clinical Innovations, LLC:
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

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014