PROMComplete for Determination of Rupture of Fetal Membranes
(PROMComplete
Clinical Evaluation of PRO-MComplete as an Aid in Determination of Rupture of Fetal Membranes
1 other identifier
observational
600
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 25, 2018
April 1, 2018
3.3 years
February 17, 2015
April 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 20 weeks
Secondary Outcomes (1)
Occurrence of discordant examination
up to 20 weeks
Interventions
Study design is non-interventional. Patient therapy will not be affected by study participation.
Eligibility Criteria
The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 20 to 42 weeks gestation.
You may qualify if:
- Subject has provided verbal and written informed consent to participate in the study.
- weeks of gestation.
- Subject presents with signs and/or symptoms of premature rupture of membranes.
- Subject age 18 (years) or older
You may not qualify if:
- Placenta Previa
- Presenting with vaginal bleeding
- Intravaginal ultrasound with presence of transducer gel
- Active labor
- Imminent delivery
- Intercourse within 24 hours
- Cord prolapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Alabama Hospital
Birmingham, Alabama, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Methodist Hospital Dallas
Dallas, Texas, 75203, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229, United States
Christus Santa Rosa Westover Hills
San Antonio, Texas, 78251, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Related Publications (8)
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.
PMID: 17400872BACKGROUNDPractice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
PMID: 24084566BACKGROUNDWomen'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
BACKGROUNDBornstein 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.
PMID: 16841279BACKGROUNDMercer 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.
PMID: 15519427BACKGROUNDEl-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.
PMID: 20569537BACKGROUNDCousins 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.
PMID: 16118720BACKGROUNDChen 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.
PMID: 18548399BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrew Rae
Pro-Lab Diagnostic VP
- PRINCIPAL INVESTIGATOR
Hector Chapa, M.D.
Methodist Medical Center Dallas
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
February 24, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 25, 2018
Record last verified: 2018-04