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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of L'Aquila.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Casa Sollievo della Sofferenza IRCCS
University of Palermo
Information provided by (Responsible Party):
Guglielmo Mariani, University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01276964
First received: January 11, 2011
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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.


Condition
Validate QUEM Method
Quantitative Determination of Menses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of L'Aquila:

Biospecimen Retention:   Samples With DNA

Soiled oads and tampons, vacuum sealed are retained till their evaluation, they will be appropiately discharged after their analysis


Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1. Women in the fertile age
Healthy women in the fertile age (between 20-45 years) with apparently normal periods

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).

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women in the fertile age with apparently normal cycles

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276964

Contacts
Contact: guglielmo mariani, md 0862368208 gmprivate39@gmail.com
Contact: mariasanta napolitano, md 0862368741 marysanta@libero.it

Locations
Italy
University of L'Aquila Recruiting
L'aquila, Italy, 67100
Contact: napolitano       marysanta@libero.it   
Principal Investigator: napolitano mariasanta, md         
University of Palermo Active, not recruiting
Palermo, Italy, 90127
Casa Sollievo Della Sofferenza Irccs Recruiting
San Giovanni Rotondo, Italy, 71013
Contact: grandone       grandone@katamail.com   
Principal Investigator: elvira grandone, md         
Sponsors and Collaborators
University of L'Aquila
Casa Sollievo della Sofferenza IRCCS
University of Palermo
Investigators
Principal Investigator: mariasanta napolitano, md univeristy of perugia, hospital of l'aquila
Study Director: guglielmo mariani, md University of L'Aquila
  More Information

Additional Information:
No publications provided

Responsible Party: Guglielmo Mariani, Prof, University of L'Aquila
ClinicalTrials.gov Identifier: NCT01276964     History of Changes
Other Study ID Numbers: MEVA-1/2007
Study First Received: January 11, 2011
Last Updated: July 13, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by University of L'Aquila:
menses
quantitative determination of menstrual losses
kinetic definition of menses

ClinicalTrials.gov processed this record on October 02, 2014