Clinical trial NCT01366443: Analysis of ROM Plus to Detect Rupture of Membranes
Official title: Analysis of ROM Plus to Detect Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rupture of Amniotic Membranes
Keywords: 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
Lead sponsor: Clinical Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: Midwestern University
name: The Reading Hospital and Medical Center
name: University of Utah
First posted: 2011-06-06
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Exclusion Criteria:

* Known placental previa
* Active vaginal bleeding

Primary outcomes:
measure: Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
References:
citation: 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.