Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369012
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-09
Brief Title:
Management of Abnormal Uterine Bleeding
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Randomized Trial of Mefenamic Acid Versus Tranexamic Acid in Management of Abnormal Uterine Bleeding
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abnormal uterine bleeding AUB describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation problems related to pregnancy infections vaginal and cervical abnormalities uterine pathologies including benign and malignant tumors coagulopathies endocrine disorders trauma foreign bodies systemic diseases and iatrogenic causes AUB may be clinically presented by menorrhagia metrorrhagia or menometrorrhagia Its the most common complaint for the reproductive age females and accounts for 33 of female patients referred to gynecologists
Detailed Description:
Menorrhagia if repeated causes a decrease in iron reserve and anemia and subsequently anemia causes psychological and cardiac complications and dysfunction in other organs So paying attention to menorrhagia and its treatment can lead to lower morbidity in reproductive aged women It is worth noticing that most of the iron deficient anemia morbidities are the result of more than 60 ml bleeding per cycle
The evaluation of the actual bleeding volume is not an easy task because womens evaluation of their own bleeding volume is not reliable 25 of the women who consider their bleeding level as high had menstrual bleeding less than 35 ml The estimation of blood loss volume was done based on the number of pads or tampons soaking per day or per cycle The patients estimations of the bleeding volumes are not accurate and reliable because they are not well aware of the normal range of bleeding and their evaluations are inexact
Ideally a noninvasive investigation is preferred to an invasive one and also an economical investigation preferred to an expensive one this applies equally to affluent countries and third world that is why ultrasonography by any modality if available is considered to be a noninvasive procedure to investigate uterine lesions rather than hysteroscopy as a preliminary step
Various imaging techniques are used to enable the precise localization and characterization of uterine pathology Currently the main diagnostic tools for AUB include ultrasonography and diagnostic hysteroscopy
Menorrhagia is defined as complaint of heavy menstrual bleeding over several consecutive cycles The upper limit of monthly bleeding is 80 ml per cycle which is 2 standard deviations from the mean mean menstrual bleeding per cycle is 36 - 52ml
Worldwide use of hormonal therapy is based on the wrong assumption that menorrhagia happens because of imbalance in hormones and an ovulatory cycle but the fact is most of the women with abnormal bleeding show no evidence of hormonal imbalance and based on some studies 95 have regular ovulatory cycles
Antifibrinolytic medications such tranexamic acid function by inhibiting the breakdown of fibrin and are useful in the management of individuals with persistent AUB It has been demonstrated that they can cut bleeding in these patients by 30 to 55 For the treatment of acute AUB experts advise utilizing tranexamic acid intravenously IV or orally
In another study the treatment of menorrhagia by both mefenamic acid and tranexamic acidthey were beneficial in controlling menstrual blood loss with significant decrease in dysmenorrhea Minor side effects like epigastric pain nausea vomiting was more frequent in mefenamic acid group Acceptability rate was high in both groups
The evaluation of the actual bleeding volume is not an easy task because womens evaluation of their own bleeding volume is not reliable 25 of the women who consider their bleeding level as high had menstrual bleeding less than 35 ml The estimation of blood loss volume was done based on the number of pads or tampons soaking per day or per cycle The patients estimations of the bleeding volumes are not accurate and reliable because they are not well aware of the normal range of bleeding and their evaluations are inexact
Ideally a noninvasive investigation is preferred to an invasive one and also an economical investigation preferred to an expensive one this applies equally to affluent countries and third world that is why ultrasonography by any modality if available is considered to be a noninvasive procedure to investigate uterine lesions rather than hysteroscopy as a preliminary step
Various imaging techniques are used to enable the precise localization and characterization of uterine pathology Currently the main diagnostic tools for AUB include ultrasonography and diagnostic hysteroscopy
Menorrhagia is defined as complaint of heavy menstrual bleeding over several consecutive cycles The upper limit of monthly bleeding is 80 ml per cycle which is 2 standard deviations from the mean mean menstrual bleeding per cycle is 36 - 52ml
Worldwide use of hormonal therapy is based on the wrong assumption that menorrhagia happens because of imbalance in hormones and an ovulatory cycle but the fact is most of the women with abnormal bleeding show no evidence of hormonal imbalance and based on some studies 95 have regular ovulatory cycles
Antifibrinolytic medications such tranexamic acid function by inhibiting the breakdown of fibrin and are useful in the management of individuals with persistent AUB It has been demonstrated that they can cut bleeding in these patients by 30 to 55 For the treatment of acute AUB experts advise utilizing tranexamic acid intravenously IV or orally
In another study the treatment of menorrhagia by both mefenamic acid and tranexamic acidthey were beneficial in controlling menstrual blood loss with significant decrease in dysmenorrhea Minor side effects like epigastric pain nausea vomiting was more frequent in mefenamic acid group Acceptability rate was high in both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None