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

April 24, 2018 updated by: Pro-Lab Diagnostics

Clinical Evaluation of PRO-MComplete as an Aid in Determination of Rupture of Fetal Membranes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Recruiting
        • University of Alabama Hospital
        • Contact:
          • Nancy Saxon, RN
        • Principal Investigator:
          • Alan Tita, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • David Haas, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75203
        • Active, not recruiting
        • Methodist Hospital Dallas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Sciences Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Omeotl Acosta, M.D.
      • San Antonio, Texas, United States, 78251
        • Recruiting
        • Christus Santa Rosa Westover Hills
        • Contact:
        • Principal Investigator:
          • Carlos Quezada, M.D.
    • Utah
      • Salt Lake City, Utah, United States
        • Recruiting
        • University of Utah Hospital
        • Contact:
          • Sarah Lopez, RN
        • Principal Investigator:
          • Erin Clark, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pro-Lab Diagnostics

Investigators

  • Study Director: Andrew Rae, Pro-Lab Diagnostic VP
  • Principal Investigator: Hector Chapa, M.D., Methodist Medical Center Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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