Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles
NCT ID: NCT01276964
Last Updated: 2012-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2007-09-30
2012-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1. Women in the fertile age
Healthy women in the fertile age (between 20-45 years) with apparently normal periods
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Referred normal menses .Use of the same brand of sanitary protection wear for the whole of the period.
* BMI between 18 and 30
Exclusion Criteria
* Positive gynecological history of fibroids, polyps or malignancy
* Treatment with anti-coagulants, antifibrinolytics, non steroidal anti-inflammatory agents
* Use of oral contraceptives in past three months
* Use of intrauterine devices (IUDs) in past three months .Hgb levels \<12 g/dl and Ferritin \<25 ng/ml.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Casa Sollievo della Sofferenza IRCCS
OTHER
University of Palermo
OTHER
University of L'Aquila
OTHER
Responsible Party
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Guglielmo Mariani
Prof
Principal Investigators
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mariasanta napolitano, md
Role: PRINCIPAL_INVESTIGATOR
univeristy of perugia, hospital of l'aquila
guglielmo mariani, md
Role: STUDY_DIRECTOR
University of L'Aquila
Locations
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University of Palermo
Palermo, Italy, Italy
Casa Sollievo Della Sofferenza Irccs
San Giovanni Rotondo, Italy, Italy
University of L'Aquila
L’Aquila, , Italy
Countries
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Central Contacts
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Facility Contacts
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grandone
Role: primary
napolitano
Role: primary
Related Links
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The official site of Italian Society of Obstetrics and Gynecology
Official site of the American Society of Obstetrics and Gynecology for women's healthcare physicians
Other Identifiers
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MEVA-1/2007
Identifier Type: -
Identifier Source: org_study_id