Analysis of ROM Plus to Detect Rupture of Membranes

Rupture of Amniotic Membranes Clinical Trial

Official title:

Analysis of ROM Plus to Detect Rupture of Membranes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366443
• Other study ID #: ROM Plus Clinical Study
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: July 30, 2012
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Clinical Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Exclusion Criteria:

• Known placental previa

• Active vaginal bleeding

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rupture
• Rupture of Amniotic Membranes

Intervention

Procedure:
• Sterile speculum exam
Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
• ROM Plus Exam
Vaginal swab exam for ROM Plus Test
• Chart Reveiw
Post delivery blinded chart review by expereienced obstetrician

Locations

Country	Name	City	State
United States	University of Utah Medical Center	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
Clinical Innovations, LLC	Midwestern University, The Reading Hospital and Medical Center, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus	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.	1 week	No