Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 11, 2011
July 13, 2012
September 2007
September 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01276964 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles
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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

women in the fertile age with apparently normal cycles

  • Validate QUEM Method
  • Quantitative Determination of Menses
Not Provided
1. Women in the fertile age
Healthy women in the fertile age (between 20-45 years) with apparently normal periods
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Female
20 Years to 45 Years
Yes
Contact: guglielmo mariani, md 0862368208 gmprivate39@gmail.com
Contact: mariasanta napolitano, md 0862368741 marysanta@libero.it
Italy
 
NCT01276964
MEVA-1/2007
Yes
Guglielmo Mariani, University of L'Aquila
University of L'Aquila
  • Casa Sollievo della Sofferenza IRCCS
  • University of Palermo
Principal Investigator: mariasanta napolitano, md univeristy of perugia, hospital of l'aquila
Study Director: guglielmo mariani, md University of L'Aquila
University of L'Aquila
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP