Premature Rupture of Membranes Clinical Trial
Official title:
A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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