PROMComplete for Determination of Rupture of Fetal Membranes
NCT ID: NCT02369601
Last Updated: 2018-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2015-08-31
2018-12-31
Brief Summary
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PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.
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Detailed Description
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The classic clinical presentation of PROM is a sudden "gush" of clear or pale yellow fluid from the vagina. However, many women describe intermittent or constant leaking of small amounts of fluid or just a sensation of wetness within the vagina or on the perineum (WHEC 2009).
However, the diagnosis of PROM is difficult if there is a slow fluid leak or any bleeding, or when the classic "gush of fluid "does not occur (Bornstein 2006).
Although ultrasonographically guided transabdominal instillation of indigo carmine dye and observation for fluid passage transvaginally is designated an "unequivocal" diagnostic method for confirmation of membrane rupture, this invasive test carries increased maternal and fetal risk (Mercer 2004). The absence of a non-invasive "gold standard" for the diagnosis of PROM has led to technically advanced biochemical markers for improved diagnosis (El-Messidi, 2010).
The AmniSure ROM (Rupture of Membranes) test received Food and Drug Administration 510(k) marketing clearance in 2003. A comparison study of AmniSure versus standard diagnostic methods for detection of ROM in 203 pregnant women suspected of ROM reported that the AmniSure test was highly accurate (sensitivity = 98.9 %, specificity = 100 %, and negative predictive value \[NPV\] = 99.1 %) in diagnosing ROM (Cousins et al, 2005). Test performance was calculated by comparing AmniSure results against clinical history, nitrazine and fern results, presence of pooling, ultrasound (US) evidence of oligohydramnios, and findings from repeated examinations.
Chen and Dudenhausen (2008) compared 2 rapid strip tests for the detection of amniotic fluid, based on the detection of insulin-like growth factor-binding protein-1 (IGFBP-1) and of PAMG-1. Samples of amniotic fluid were taken in 20 pregnant women between 31 3/7 and 41 2/7 gestational weeks at elective cesarean section before delivery of the newborn. These samples were diluted with 0.9 % saline solution in a dilution series down to concentrations of 1:320. Immunoassay strip tests were then compared in their ability to detect remaining concentrations of amniotic fluid. In 5 cases, both test methods showed the same results. In all remaining 15 cases, the test based on PAMG-1 proved to be superior by detecting amniotic fluid at least at one descending concentration below the test based on IGFBP-1.
PRO-MComplete proposes an alternative tool for adjuvant diagnosis of PROM by identification of Insulin-Like Growth Factor Binding Protein1 and Alpha Feto- Protein (AFP). The addition of AFP is projected to increase the sensitivity and specificity of PRO-MComplete over IGFBP-1 alone.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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non- intervention study
Study design is non-interventional. Patient therapy will not be affected by study participation.
Eligibility Criteria
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Inclusion Criteria
2. 20-42 weeks of gestation.
3. Subject presents with signs and/or symptoms of premature rupture of membranes.
4. Subject age 18 (years) or older
Exclusion Criteria
2. Presenting with vaginal bleeding
3. Intravaginal ultrasound with presence of transducer gel
4. Active labor
5. Imminent delivery
6. Intercourse within 24 hours
7. Cord prolapse
18 Years
45 Years
FEMALE
No
Sponsors
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Pro-Lab Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Rae
Role: STUDY_DIRECTOR
Pro-Lab Diagnostic VP
Hector Chapa, M.D.
Role: PRINCIPAL_INVESTIGATOR
Methodist Medical Center Dallas
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
Indiana University
Indianapolis, Indiana, United States
Methodist Hospital Dallas
Dallas, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Christus Santa Rosa Westover Hills
San Antonio, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Nancy Saxon, RN
Role: primary
Sarah Lopez, RN
Role: primary
References
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ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007 Apr;109(4):1007-19. doi: 10.1097/01.AOG.0000263888.69178.1f.
Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
Women's Health and Education Center, Obstetrics: Premature Rupture of Membranes: Diagnosis and Management. http://www.womenshealthsection.com/content/obs/obs021.php3 Accessed July 13, 2009
Bornstein J, Geva A, Solt I, Fait V, Schoenfeld A, Shoham HK, Sobel J. Nonintrusive diagnosis of premature ruptured amniotic membranes using a novel polymer. Am J Perinatol. 2006 Aug;23(6):351-4. doi: 10.1055/s-2006-947159. Epub 2006 Jul 13.
Mercer BM. Preterm premature rupture of the membranes: diagnosis and management. Clin Perinatol. 2004 Dec;31(4):765-82, vi. doi: 10.1016/j.clp.2004.06.004.
El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X.
Cousins LM, Smok DP, Lovett SM, Poeltler DM. AmniSure placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005 Aug;22(6):317-20. doi: 10.1055/s-2005-870896.
Chen FC, Dudenhausen JW. Comparison of two rapid strip tests based on IGFBP-1 and PAMG-1 for the detection of amniotic fluid. Am J Perinatol. 2008 Apr;25(4):243-6. doi: 10.1055/s-2008-1066876.
Other Identifiers
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PROMC001
Identifier Type: -
Identifier Source: org_study_id
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