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临床试验/NCT06369012
NCT06369012已完成不适用

Randomized Trial of Mefenamic Acid Versus Tranexamic Acid in Management of Abnormal Uterine Bleeding

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Bleeding Control

研究概览

简要总结

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. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists

详细描述

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 women's 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 patient's 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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Any female patient in Child bearing period aging from 15-45 years complaining of Abnormal uterine.
  • Abnormal uterine bleeding due to endometrial, uterine cavity lesions as diagnosed by TVS or bleeding tendency e.g. Thrombocytopenia, Platelets dysfunction and coagulation defects

排除标准

  • Personal history of renal or hepatic impairment; previous thromboembolic disease, peptic ulcer.
  • Females with evident drugs intake that cause AUB e.g warfarin, low molecular weight heparin.
  • Vaginal, vulvar, and cervical causes of bleeding.
  • Bleeding on top of Use of hormonal and non-hormonal contraception.

研究组 & 干预措施

Group A : Mefenamic acid

Active Comparator

About 65 women will take Mefenamic acid tablets orally, 3 timed per day.This regiment can be repeated for at least three attacks of Abnormal Uterine Bleeding.

(Mefenamic acid manufactured by JPI pharmaceutical company)

干预措施: Mefenamic acid 500 mg (Drug)

Group B: Tranexamic acid

Active Comparator

About 65 women will take Tranexamic acid capsules orally, 3 time per day .This regiment can be repeated for at least three attacks of Abnormal Uterine Bleeding.

(Tranexamic acid manufactured by AMOUN pharmaceutical company)

干预措施: Mefenamic acid 500 mg (Drug)

结局指标

主要结局

Bleeding Control

时间窗: 1 week

The paricipants of the study whom having abnormal uterine bleeding will be asked to take the drugs of the study to see the amount of blood will decrease or not

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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