Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles

Quantitative Determination of Menses Clinical Trial

— MEVA-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01276964
• Other study ID #: MEVA-1/2007
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2011
• Last updated: July 13, 2012
• Start date: September 2007
• Est. completion date: September 2012

Study information

• Verified date: July 2012
• Source: University of L'Aquila
• Contact: guglielmo mariani, md
• Phone: 0862368208
• Email: gmprivate39[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Quantitative Determination of Menses
• Validate QUEM Method

Locations

Country	Name	City	State
Italy	University of L'Aquila	L'aquila
Italy	University of Palermo	Palermo
Italy	Casa Sollievo Della Sofferenza Irccs	San Giovanni Rotondo

Sponsors (3)

Lead Sponsor	Collaborator
University of L'Aquila	Casa Sollievo della Sofferenza IRCCS, University of Palermo

Country where clinical trial is conducted

Italy, 

External Links

•   Official site of the American Society of Obstetrics and Gynecology for women's healthcare physicians
•   The official site of Italian Society of Obstetrics and Gynecology