Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles (MEVA-1)

July 13, 2012 updated by: Guglielmo Mariani, University of L'Aquila

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • L'aquila, Italy, 67100
        • Recruiting
        • University of L'Aquila
        • Contact:
        • Principal Investigator:
          • napolitano mariasanta, md
      • Palermo, Italy, 90127
        • Active, not recruiting
        • University of Palermo
      • San Giovanni Rotondo, Italy, 71013
        • Recruiting
        • Casa Sollievo Della Sofferenza IRCCS
        • Contact:
        • Principal Investigator:
          • elvira grandone, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women in the fertile age with apparently normal cycles

Description

Inclusion Criteria:

  • Women in the fertile age (between 20-45 years), not assuming oral contraceptives from at least three months
  • 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:

  • Abnormal Bleeding Score
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1. Women in the fertile age
Healthy women in the fertile age (between 20-45 years) with apparently normal periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Collaborators

University of Palermo
Casa Sollievo della Sofferenza IRCCS

Investigators

  • Principal Investigator: mariasanta napolitano, md, univeristy of perugia, hospital of l'aquila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (Estimate)

January 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEVA-1/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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