Rapid Immunoassay Tests for the Detection of Ruptured Membranes
- Conditions
- Premature Rupture of Membranes
- Interventions
- Other: Use of Rapid Immunoassay Tests for the Detection of PROM
- Registration Number
- NCT02495441
- Lead Sponsor
- De Soysa Hospital for Women
- Brief Summary
The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.
- Detailed Description
Premature rupture of membranes (PROM) is defined as spontaneous rupture of membranes (ROM) before the onset of uterine contractions. Its diagnosis is often obvious with the woman presenting with leakage of amniotic fluid, but it could also turn out to be a difficult diagnostic dilemma.
The diagnosis of fetal membrane rupture is conventionally made using a clinical assessment. First, by speculum examination, the clinician looks for amniotic fluid leaking from the cervical os. If clear fluid is visualized leaking from the cervical os, the diagnosis is positive for fetal membrane rupture. More commonly, leaking is absent, and a more extensive workup is required, which includes nitrazine/pH testing, visual inspection of pooling of fluid in the posterior fornix, and a microscopic evaluation of the collected specimen (ferning). Although this approach is considered the standard of care, it is fraught with inaccuracies, requires an intrusive examination and may not provide a rapid diagnosis.
Rapid, point of care, qualitative immunochromatographic tests (ie., Amnisure®, ActimProm®, Amnioquick® Complete and ROM Plus®) that detect proteins found in amniotic fluid at high concentrations, have been used to diagnose the rupture of membranes (ROM) for several years. In many hospitals, Amnisure® has replaced the sterile speculum exam as the standard of care for diagnosing ROM. It identifies Placental Alpha Microglobulin-1 (PAMG-1), a 34 kd fetal glycoprotein, in cervicovaginal secretions.
ROM Plus® ActimProm®and Amnioquick® Complete+ are newer additions into the market for testing for PROM. Both these tests use a monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations. They detect Placental Protein-12 (also known as Insulin-like Growth Factor Binding Protein-1 - IGFBP-1) as well as Alpha Fetoprotein (AFP).
The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure®. Stated in statistical terms, the aim is to demonstrated that IGFBP-1/AFP tests are non-inferior to Amnisure® in terms of sensitivity and specificity when both are compared in a paired-sample fashion to a common referent standard (gold standard), which is clinical assessment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment
- Known placental previa
- Active vaginal bleeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dribbling group Use of Rapid Immunoassay Tests for the Detection of PROM Any woman who presents with alleged leakage of amniotic fluid. They will under go rapid Immunoassay Tests for the Detection of PROM
- Primary Outcome Measures
Name Time Method Number of participants that become positive for pre labor rupture of membranes by the immunological test kits. up to 1 year This will be assessed by the performing 4 immunological tests and clinical assessment. These test kits includes ROM Plus, ActimProm®, Amnioquick® and Amnisure. Outcomes of the immune tests will be compared against a gold stranded clinical assessment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
De Soyza Hospital for Women
🇱🇰Colombo, Western, Sri Lanka