Evaluation of Menses in Congenital Bleeding Disorders (MEVA-3)
Recruitment status was Recruiting
|First Received Date ICMJE||December 16, 2010|
|Last Updated Date||December 16, 2010|
|Start Date ICMJE||February 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Quantitative determination of menstrual blood losses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quantitative determination of menstrual blood losses in women in the fertile age( between 18 and 45 years) affected by an inherited haemorrhagic disorder diagnosed on the basis of the current International Standard Criteria.This study is preliminary to the evaluation of the efficacy of each
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of Menses in Congenital Bleeding Disorders|
|Official Title ICMJE||Protocol for the Determination of Menstrual Blood Losses in Women Affected by Congenital Bleeding Disorders|
Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have been proposed to define this symptom: 60 on each cycle has also been confirmed in our preliminary study on 87 healthy women. The quantitative determination of menstrual blood losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a quite frequent symptom in healthy women apparently haemostatically competent in the fertile age (20-30%), its incidence becomes very high in women affected by congenital coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom "menorrhagia" has an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported.
This explains the need for a study focused on the evaluation of menorrhagia in CBDs, addressed to answer to the following, still unsolved questions:
The following is a multicentric, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women affected by Congenital Bleeding Disorders (CBDs).
The evaluation of menstrual losses represents a scarcely studied field in this specific subset of patients (1), but it is very interesting because of the high incidence of menorrhagia,changeable according to each type of CBDs, but between 60 and 100% in women in the fertile age.
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 87 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 women in the fertile age (between 18 e 45 years),with an ascertained diagnosis of CBD (FVII, FX, FII deficiencies, Glanzmann and von Willebrand disease, symptomatic Hemophilia A and B carriers), followed up for heavy periods at their reference hemophilia centre and needing a specific treatment will be enrolled in this multicentric study. Also women with apparently normal menses but a severe bleeding disorder will be enrolled. Women with ascertained menorrhagia will be treated with specific replacement therapies, already commonly adopted in clinical practice based on the type of CBD and scheduled to reduce heavy periods.
The study will evaluate 4 consecutive menstrual cycles, the first and the second period without treatment (when possible) and the following two by the administration of the specific treatment.
The bleeding anamnesis (bleeding score) will be performed by applying an international reference method, already validated in von Willebrand Disease type 1 (vWD1)  and adopted in an Italian multicentric study on 814 patients affected by different types of VWD . The determination of this score has been considered useful also for other CBDs. This study has already been approved by the IRC of "San Salvatore Hospital"- L'Aquila-Italy. The study is already enrolling, in Italy, women. All the needed materials and equipments will be provided; 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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case-Crossover
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Vacuum sealed soiled pads and tampons, will be weighted and than opportunely discarghed
|Sampling Method||Non-Probability Sample|
|Study Population||Women affected by CBDs and candidated to receive, as commonly performed in clinical practice a specific substitutive therapy or Desmopressine (rFVIII, rFVIIa, Desmopressine , FVIII concentrates rich in VWF, Activated Prothrombin Complex) will be followed for four consecutive menseses .The number of women enrolled will be between 30 and 50, regardless of parity.|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||women with a diagnosis of CBD
women in the fertile age, with an ascertained diagnosis of CBD, followed up for heavy periods and needing a specific treatment.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||30|
|Estimated Completion Date||December 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
1. Under continuous anti-hemorrhagic prophylaxis 2. Affected by an active cancer or anti-phospholipid antibodies syndrome 3. History of liver, kidney or endocrine disorders 4. Submucous uterine fibroids, uterine polyps or malignancy 5. Use of oral contraceptives or intrauterine devices in the past three months 6. Treatment with non-steroidal anti-inflammatory drugs
|Ages||18 Years to 45 Years|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||Italy|
|Removed Location Countries|
|NCT Number ICMJE||NCT01261936|
|Other Study ID Numbers ICMJE||MEVA-3|
|Has Data Monitoring Committee||No|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Napolitano Mariasanta,MD, Ospedale Sna Salvatore-U.O.C. di Medicina Interna ed Ematologia-L'Aquila|
|Study Sponsor ICMJE||University of L'Aquila|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of L'Aquila|
|Verification Date||December 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP