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PROMComplete for Determination of Rupture of Fetal Membranes ((PROMComplete)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369601
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pro-Lab Diagnostics

Brief Summary:

Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased incidence of perinatal mortality and intra-amniotic infection. There is a need for improved diagnostic testing because of limitations of the current methods.

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.


Condition or disease Intervention/treatment
Fetal Membranes, Premature Rupture Other: non- intervention study

Detailed Description:

Premature rupture of membranes (PROM) complicates approximately 8 % of pregnancies and is generally followed by the prompt onset of spontaneous labor and delivery. Preterm PROM complicates only 2 % of pregnancies but is associated with 40% of preterm deliveries and can result in significant neonatal morbidity and mortality (ACOG 2007). Intraamniotic infection has been shown to be commonly associated with preterm PROM, especially at earlier gestational ages (ACOG 2013). Currently, the diagnosis of PROM is based primarily on the patient's history and physical examination. The diagnosis of membrane rupture typically is confirmed by the visualization of amniotic fluid passing from the cervical canal and pooling in the vagina; a basic pH test of vaginal fluid; or arborization (ferning) of dried vaginal fluid, which is identified under microscopic evaluation (ACOG 2013).

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of PRO-MComplete as an Aid in Determination of Rupture of Fetal Membranes
Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears


Intervention Details:
  • Other: non- intervention study
    Study design is non-interventional. Patient therapy will not be affected by study participation.


Primary Outcome Measures :
  1. accuracy of Pro-mcomplete vs conventional testing for ruptured fetal membranes [ Time Frame: up to 20 weeks ]
    All eligible subjects will be evaluated clinically and will be tested with appropriate reference tests as well as the PRO-MComplete test. Subjects tested with Pro-mcomplete will be followed until delivery of index pregnancy. Final subject evaluation will occur with index delivery.


Secondary Outcome Measures :
  1. Occurrence of discordant examination [ Time Frame: up to 20 weeks ]
    Documentation of frequency of device and clinical examination incongruent results. Pregnancy outcomes will be reviewed for all test subjects, not just the test incongruent cohort.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 20 to 42 weeks gestation.
Criteria

Inclusion Criteria:

  1. Subject has provided verbal and written informed consent to participate in the study.
  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:

  1. Placenta Previa
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369601


Contacts
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Contact: Andrew Rae +1 905 731 0300 arae@pro-lab.com
Contact: Chris Dunn 512-626-2590 chris.dunn@pro-lab.com

Locations
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United States, Alabama
University of Alabama Hospital Recruiting
Birmingham, Alabama, United States
Contact: Nancy Saxon, RN         
Principal Investigator: Alan Tita, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jessica Mockler       jelyroby@iupui.edu   
Principal Investigator: David Haas, MD         
United States, Texas
Methodist Hospital Dallas Active, not recruiting
Dallas, Texas, United States, 75203
University of Texas Health Sciences Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Omeotl Acosta, M.D.       Acostao@uthscsa.edu   
Principal Investigator: Omeotl Acosta, M.D.         
Christus Santa Rosa Westover Hills Recruiting
San Antonio, Texas, United States, 78251
Contact: Carlos Quezada, M.D.       drpapiq@gmail.com   
Principal Investigator: Carlos Quezada, M.D.         
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States
Contact: Sarah Lopez, RN         
Principal Investigator: Erin Clark, MD         
Sponsors and Collaborators
Pro-Lab Diagnostics
Investigators
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Study Director: Andrew Rae Pro-Lab Diagnostic VP
Principal Investigator: Hector Chapa, M.D. Methodist Medical Center Dallas

Publications:
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

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Responsible Party: Pro-Lab Diagnostics
ClinicalTrials.gov Identifier: NCT02369601    
Other Study ID Numbers: PROMC001
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Pro-Lab Diagnostics:
amniorrhexis
Ruptured membranes
Alfa-fetoprotein
Additional relevant MeSH terms:
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Fetal Membranes, Premature Rupture
Rupture
Wounds and Injuries
Obstetric Labor Complications
Pregnancy Complications