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.
Full Title of Study: “A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: December 2015
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.
- Other: Use of Rapid Immunoassay Tests for the Detection of PROM
- After informed consent , both the ROM Plus®, ActimProm Amnioquick® Complete and AmniSure® bedside tests (without the use of a speculum) will be performed. The patient will then undergo the standard clinical assessment, which includes a sterile speculum exam (SSE). If either 1) amniotic fluid is seen leaking from the cervical os, or 2) if at least two of the following three clinical signs are present: visual pooling of fluid in the posterior fornix, positive nitrazine test, and microscopic evidence of ferning, then the patient will be considered positive for ROM. Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of IGFBP-1/AFP tests and Amnisure®.
Arms, Groups and Cohorts
- Dribbling group
- Any woman who presents with alleged leakage of amniotic fluid. They will under go rapid Immunoassay Tests for the Detection of PROM
Clinical Trial Outcome Measures
- Number of participants that become positive for pre labor rupture of membranes by the immunological test kits.
- Time Frame: 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.
Participating in This Clinical Trial
- Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment
- Known placental previa
- Active vaginal bleeding
Gender Eligibility: Female
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- De Soysa Hospital for Women
- Clinical Innovations, LLC
- Provider of Information About this Clinical Study
- Principal Investigator: Hemantha M. Senanayake, Professor of Obstetrics and Gynecology – De Soysa Hospital for Women
- Overall Official(s)
- Hemantha Senanayake, MS, FRCOG, Principal Investigator, Department of Obstetrics & Gynaecology Faculty of Medicine University of Colombo, Sri Lanka
- Overall Contact(s)
- Hemantha Senanayake, MS, FRCOG, +94714762176, firstname.lastname@example.org,
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