Evaluation of Menses in Congenital Bleeding Disorders (MEVA-3)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of L'Aquila.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01261936
First received: December 16, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 16, 2010
December 16, 2010
February 2010
Not Provided
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
Same as current
No Changes Posted
  • kinetic definition of menses [ Time Frame: monthly ] [ Designated as safety issue: No ]
    Kinetic definition of menses (hours and days of flow) with and without specific treatment
  • Influence of treatment on menstrual blood losses [ Time Frame: monthly ] [ Designated as safety issue: No ]
    To define the influence of substitutive therapies on menstrual losses
  • treatment schedule evaluation [ Time Frame: monthly ] [ Designated as safety issue: No ]
    Elaboration of specific treatment schedules for each type of CBD, as evaluated by QUEM
Same as current
Not Provided
Not Provided
 
Evaluation of Menses in Congenital Bleeding Disorders
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:

  1. Definition of the entity of menstrual blood losses in women affected by CBDs
  2. Elaboration of specific treatment schedules for each type of CBD
  3. Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).

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) [2] and adopted in an Italian multicentric study on 814 patients affected by different types of VWD [3]. 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).

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Vacuum sealed soiled pads and tampons, will be weighted and than opportunely discarghed

Non-Probability Sample

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.

  • Von Willebrand Disease
  • Congenital Coagulation Factors Deficiency
  • Haemophilia Carriers
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2011
Not Provided

Inclusion Criteria:

  1. Age between 18 and 45 years;
  2. Ascertained diagnosis of one of the following inherited bleeding disorders:

    1. Von Willebrand Disease type 1, 2, 3 severe and moderate (VWF:RCo < 30 %),as diagnosed following Italian guidelines [4]
    2. Glanzmann Thromboasthenia
    3. Congenital Coagulation Factor VII, II or X deficiency
    4. A and B Haemophilia Carriers (Factor VIII and IX <25%);
  3. Bleeding Severity score > 2
  4. Signing the consent form.

Exclusion Criteria:

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

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Female
18 Years to 45 Years
No
Italy
 
NCT01261936
MEVA-3
No
Napolitano Mariasanta,MD, Ospedale Sna Salvatore-U.O.C. di Medicina Interna ed Ematologia-L'Aquila
University of L'Aquila
Not Provided
Study Director: guglielmo mariani, md ospedale "san salvatore"
University of L'Aquila
December 2010

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