Fetal Membranes, Premature Rupture(PROMCompleteNCT02369601
PROMComplete for Determination of Rupture of Fetal Membranes
An observational study of Fetal Membranes, Premature Rupture, run by Pro-Lab Diagnostics at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Membranes, Premature Rupture
- What is being tested?
- non- intervention study
- How many people
- 600 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 20 to 42 weeks gestation.
Who may be able to join
- Subject has provided verbal and written informed consent to participate in the study.
- 20-42 weeks of gestation.
- Subject presents with signs and/or symptoms of premature rupture of membranes.
- Subject age 18 (years) or older
Who cannot join
- Placenta Previa
- Presenting with vaginal bleeding
- Intravaginal ultrasound with presence of transducer gel
- Active labor
- Imminent delivery
- Intercourse within 24 hours
- Cord prolapse
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
University of Alabama Hospital
Birmingham, Alabama
Nancy Saxon, RN
Alan Tita, MD
- Active, not recruiting
Methodist Hospital Dallas
Dallas, Texas, 75203
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Jessica Mockler, jelyroby@iupui.edu
David Haas, MD
- Recruiting
University of Utah Hospital
Salt Lake City, Utah
Sarah Lopez, RN
Erin Clark, MD
- Recruiting
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
Omeotl Acosta, M.D., Acostao@uthscsa.edu
Omeotl Acosta, M.D.
- Recruiting
Christus Santa Rosa Westover Hills
San Antonio, Texas, 78251
Carlos Quezada, M.D., drpapiq@gmail.com
Carlos Quezada, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Membranes, Premature Rupture
- Being tested
- non- intervention study
- Keywords
- amniorrhexis, Ruptured membranes, Alfa-fetoprotein
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non- intervention studyOther
Study design is non-interventional. Patient therapy will not be affected by study participation.
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of Pro-mcomplete vs conventional testing for ruptured fetal membranes
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.
Measured: up to 20 weeks
Secondary outcomes (1)
Occurrence of discordant examination
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.
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro-Lab Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Rae, Study director, Pro-Lab Diagnostic VPHector Chapa, M.D., Principal investigator, Methodist Medical Center Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369601
- Sponsor's protocol ID
- PROMC001
- Acronym
- (PROMComplete
- Status last verified
- Apr 2018
- First submitted
- 17 Feb 2015
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17400872Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
PubMed 24084566Women'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.
PubMed 16841279Mercer 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.
PubMed 15519427El-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.
PubMed 20569537Cousins 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.
PubMed 16118720Chen 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.
PubMed 18548399
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of PRO-MComplete as an Aid in Determination of Rupture of Fetal Membranes
- ClinicalTrials.gov ID
- NCT02369601
- Acronym / sponsor ID
- (PROMComplete / PROMC001
- Conditions
- Fetal Membranes, Premature Rupture
- Keywords
- amniorrhexis, Ruptured membranes, Alfa-fetoprotein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Pro-Lab DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 20 to 42 weeks gestation.
Key inclusion criteria (4 listed)
- Subject has provided verbal and written informed consent to participate in the study.
- 20-42 weeks of gestation.
- Subject presents with signs and/or symptoms of premature rupture of membranes.
- Subject age 18 (years) or older
Key exclusion criteria (7 listed)
- Placenta Previa
- Presenting with vaginal bleeding
- Intravaginal ultrasound with presence of transducer gel
- Active labor
- Imminent delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non- intervention studyStudy design is non-interventional. Patient therapy will not be affected by study participation. | Other | – |
Primary outcome
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.
1 secondary outcome
Occurrence of discordant examination
Time frame: up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Background: PubMed 17400872ACOG 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.
- Background: PubMed 24084566Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
- BackgroundWomen'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
- Background: PubMed 16841279Bornstein 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.
- Background: PubMed 15519427Mercer 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.
- Background: PubMed 20569537El-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.
- Background: PubMed 16118720Cousins 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.
- Background: PubMed 18548399Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Rae study director
Pro-Lab Diagnostic VP
Hector Chapa, M.D. principal investigator
Methodist Medical Center Dallas
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Membranes, Premature Rupture, run by Pro-Lab Diagnostics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Rae (+1 905 731 0300, arae@pro-lab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of Pro-mcomplete vs conventional testing for ruptured fetal membranes (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369601, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.