Quantitative Determination of Menses Clinical Trial
Official title:
Protocol for the Determination of Menstrual Losses Using a System for the Quantitative Determination of Menses (Quantitative Evaluation of Menses [QUEM] Method) and Its Application to Healthy Women With Apparently Normal Cycles
Multicenter, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women with apparently normal menses.The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses), is based on the collection of tampons and pads in standard bags which are readily vacuum sealed with a simple device for the whole of woman's period. The evaluation will be performed for the whole of one period and the analysis will be performed in comparison to the classical reference method, the Alkaline - Hematin Method, which is still considered the golden standard.
The following is a multicenter, observational, cross-over study intended to apply an easy
and simple system for the quantitative determination of menstrual losses in women with
apparently normal menses. The problem of heavy periods is associated to an high social and
physical morbidity rate; till now there are not routine methods available for the
quantitative determination of menstrual discharge, some objective methods have been applied
exclusively for research purposes because they are very difficult to perform. If we consider
the scientific data available and the frequent application of inadequate procedures for the
treatment of this problem, it seems essential to apply a practical system for the accurate
quantitative determination of menses.
The system adopted for the determination of menstrual losses, called QUEM (QUantitative
Evaluation of Menses), is based on the collection of tampons and pads in standard bags which
are readily vacuum sealed with a simple device for the whole of woman's period. QUEM has
already been validated in preliminary in vitro and ex vivo studies (both in healthy women
and in women with CBDs), by comparing it with the gold standard, the Alkaline Haematin
Method. A correlation coefficient close to 1 was obtained.
In the current study QUEM will be applied to at least 100 women in the fertile age (between
20 and 45 years) with apparently normal menses and a negative bleeding history. The
evaluation will be performed for the whole of one period and the analysis will be performed
in comparison to the classical reference method, the Alkaline - Hematin Method, which is
still considered the golden standard. At the enrollment each woman will be tested for
complete blood cells count and ferritin levels in order to exclude unknown menorrhagia. The
bleeding history (bleeding score) will be performed by applying an international reference
method, already validated for von Willebrand Disease type 1 (vWD1). The aim of the study is
to make a "normal range" and validate the effective practicality of QUEM as a preliminary
step to the clinical studies in patients suffering from menorrhagia and affected by
hemorrhagic disorders.
The current study will involve many Italian and International Centers. All the needed
materials and equipments will be provided by the Coordinator Centre; patients will be
carefully informed about the objectives of the study and they will follow a short course
illustrating the use and the characteristics of the method proposed (QUEM).
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Observational Model: Cohort, Time Perspective: Prospective