Ignite Creation Date:
2024-05-06 @ 7:22 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02524691
Status:
UNKNOWN
Last Update Posted:
2016-08-09
First Post:
2015-07-31
Brief Title:
Efficacy Study of Rapid Immunoassay Diagnostic Test Utilizing PP12 and AFP ROM Plus
Sponsor:
Clinical Innovations LLC
Organization:
Clinical Innovations LLC
Study Overview
Official Title:
Efficacy Study of Rapid Immunoassay Diagnostic Test Utilizing PP12 and AFP ROM Plus
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed to establish the level of agreement between the ROM Plus test and the diagnosis of ROM as defined by the patients clinical course with respect to a population of pregnant women who present to the clinical site with signs and symptoms suggestive of ROM
Detailed Description:
Premature rupture of membranes PROM defined as spontaneous rupture of membranes ROM before the onset of uterine contractions is one of the most common diagnostic dilemmas in contemporary obstetrical practice Premature rupture of membranes can occur at any gestational age and preterm PROM PPROM defined as PROM before 37 weeks is responsible for 20-40 of preterm births Early and accurate diagnosis of PROM would allow for gestational age-specific obstetrical interventions designed to optimize perinatal outcome and minimize serious complications such as cord prolapse preterm delivery fetal distress and infectious morbidity chorioamnionitis neonatal sepsis Conversely a false-positive diagnosis of PROM may lead to unnecessary obstetric interventions including hospitalization administration of antibiotics and corticosteroids and even induction of labor Therefore the correct and timely diagnosis of this disorder is of critical importance to the clinician because PROM and PPROM may be associated with serious maternal and neonatal consequences
The diagnosis of fetal membrane rupture is conventionally made using a clinical assessment The most common method of diagnosis includes the sterile speculum exam SSE which includes visual inspection of pooling of fluid in the posterior fornix a nitrazinepH testing of the vaginal environment and a microscopic evaluation of the collected specimen ferning If during the sterile speculum exam the clinician observes amniotic fluid leaking from the cervical os then the diagnosis of rupture can be made without the three additional evaluations Although the SSE approach is considered an acceptable standard it requires an intrusive speculum examination and may not provide a rapid or accurate diagnosis
The literature has shown the SSE to have limitations in terms of diagnostic accuracy cost and technical ease The test becomes progressively less accurate when more than one hour has elapsed after the membranes are ruptured The nitrazine assessment which is the most common method of determining the status of the membranes in hospitals today has a sensitivity reported between 90-97 but a specificity as low as 16-70 The poor specificity is thought to be due to a high rate of false-positives caused by cervicitis vaginitis and contamination with blood urine semen and antiseptic agents The reported sensitivity and specificity for the fern test are also less than adequate at 51 and 70 respectively
As a result rapid point of care qualitative immunochromatographic tests ie ROM Plus Amnisure have recently gained popularity as aids in the diagnosis of fetal membrane rupture These tests are designed to detect proteins found in amniotic fluid at high concentrations One such test ROM Plus uses a unique monoclonalpolyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations ROM Plus detects Placental Protein-12 PP-12 also known as Insulin-like Growth Factor Binding Protein-1 as well as Alpha Fetoprotein AFP The combination of PP12 and AFP were chosen not only because of their robust historical literature support as ideal protein markers for amniotic fluid but also their unique characteristics PP12 is synthesized by the decidua of the placenta and reaches a very high concentration level in the amniotic fluid early in the first trimester and stays at that level until delivery AFP is synthesized by the fetal liver and yolk sac and reaches its peak concentration late in the second trimesterearly third trimester This increases the chance that the proteins will be detected especially in the preterm patients when the diagnosis of ROM is most crucial Amnisure uses a monoclonalmonoclonal antibody approach to detect one protein Placenta-Alpha Microglobulin-1 PAMG-1
This study is designed to assess the performance sensitivity specificity PPV NPV of ROM Plus and Amnisure as compared to the standard clinical assessment including but not limited to nitrazine ferning andor sterile speculum exam confirmed by a thorough chart review after delivery
The diagnosis of fetal membrane rupture is conventionally made using a clinical assessment The most common method of diagnosis includes the sterile speculum exam SSE which includes visual inspection of pooling of fluid in the posterior fornix a nitrazinepH testing of the vaginal environment and a microscopic evaluation of the collected specimen ferning If during the sterile speculum exam the clinician observes amniotic fluid leaking from the cervical os then the diagnosis of rupture can be made without the three additional evaluations Although the SSE approach is considered an acceptable standard it requires an intrusive speculum examination and may not provide a rapid or accurate diagnosis
The literature has shown the SSE to have limitations in terms of diagnostic accuracy cost and technical ease The test becomes progressively less accurate when more than one hour has elapsed after the membranes are ruptured The nitrazine assessment which is the most common method of determining the status of the membranes in hospitals today has a sensitivity reported between 90-97 but a specificity as low as 16-70 The poor specificity is thought to be due to a high rate of false-positives caused by cervicitis vaginitis and contamination with blood urine semen and antiseptic agents The reported sensitivity and specificity for the fern test are also less than adequate at 51 and 70 respectively
As a result rapid point of care qualitative immunochromatographic tests ie ROM Plus Amnisure have recently gained popularity as aids in the diagnosis of fetal membrane rupture These tests are designed to detect proteins found in amniotic fluid at high concentrations One such test ROM Plus uses a unique monoclonalpolyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations ROM Plus detects Placental Protein-12 PP-12 also known as Insulin-like Growth Factor Binding Protein-1 as well as Alpha Fetoprotein AFP The combination of PP12 and AFP were chosen not only because of their robust historical literature support as ideal protein markers for amniotic fluid but also their unique characteristics PP12 is synthesized by the decidua of the placenta and reaches a very high concentration level in the amniotic fluid early in the first trimester and stays at that level until delivery AFP is synthesized by the fetal liver and yolk sac and reaches its peak concentration late in the second trimesterearly third trimester This increases the chance that the proteins will be detected especially in the preterm patients when the diagnosis of ROM is most crucial Amnisure uses a monoclonalmonoclonal antibody approach to detect one protein Placenta-Alpha Microglobulin-1 PAMG-1
This study is designed to assess the performance sensitivity specificity PPV NPV of ROM Plus and Amnisure as compared to the standard clinical assessment including but not limited to nitrazine ferning andor sterile speculum exam confirmed by a thorough chart review after delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None