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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 2, 2011
Last Updated Date	July 30, 2012
Start Date ^ICMJE	September 2010
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 3, 2011)	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.
Change History	Complete list of historical versions of study NCT01366443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Analysis of ROM Plus to Detect Rupture of Membranes
Official Title ^ICMJE	Analysis of ROM Plus to Detect Rupture of Membranes
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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Rupture of Amniotic Membranes
Intervention ^ICMJE	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
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	288
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Exclusion Criteria: Known placental previa Active vaginal bleeding
Gender	Female
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01366443
Other Study ID Numbers ^ICMJE	ROM Plus Clinical Study
Has Data Monitoring Committee	Yes
Responsible Party	Clinical Innovations, LLC
Study Sponsor ^ICMJE	Clinical Innovations, LLC
Collaborators ^ICMJE	Midwestern University The Reading Hospital and Medical Center University of Utah
Investigators ^ICMJE	Not Provided
Information Provided By	Clinical Innovations, LLC
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top