Clinical trial NCT06707051: Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin
Official title: Comparison of Efficacy of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heavy. Mentrual Bleeding
Abormal utèrine Bleeding
Bleeding
Uterine Bleeding
Hypersensitivity Response
GI Disturbance
Agranulocytosis
Bleeding Pattern
Endometrial
Endometrial Bleeding
Keywords: Tranexamic acid
Calcium Dobesilate
Bleeding of endometrial origin
TXA
Lead sponsor: District Headquarters Teaching Hospital Sahiwal
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.

Detailed description: This Randomized control trial was conducted at Obstetrics \& Gynaecology unit Sahiwal Teaching Hospital from to for the period of two years after taking the approval from Institutional review board (IRB). Sample size of one hundred patients (Fifty in each group) was calculated. These patients were randomly allocated into two equal groups, fifty patients in each group. Written informed consent was obtained from each subject by explaining the risks and benefits associated with the drugs. Group A women were given 500mg tranexamic acid thrice a day for 5 days during menstrual cycle and in group B women were given 500 mg capsule Calcium dobesilate thrice a day for 5 days during menstruation for consecutive time period of three months. Women were also evaluated for adverse effects. The information was entered into specially designed proformas. The data was analyzed by SPSS version 21.0. Frequencies and percentages of categorical variables including marital status, parity and adverse effects were calculated and compared between two groups by applying chi square tests. t-Test was used for the calculation of mean and standard deviations of numerical variables like age, BMI, duration of symptoms, blood loss before and after intervention and reduction in blood loss and was compared between two groups. In all statistical analysis only p value less than 0.05 was considered significant.

Eligibility criteria: Inclusion Criteria:

* Women of 18-40 years
* Abnormal uterine bleeding

Exclusion Criteria:

* Patients with pregnancy
* Miscarriage
* Hypersensitivity to pharmacological agents to be used in trial
* Patients having moderate to severe anemia (Hb:\<8gm/dl)
* Patients with thyroid abnormalities (TSH \> 5mIU)
* Benign uterine conditions e.g. fibroid uterus, endometrial/cervical polyp
* Uterine malignancy
* Coagulation disorders (PT : \>15sec).

Primary outcomes:
measure: Reduction in blood loss
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: Sahiwal teaching Hospital Sahiwal
state: Punjab
Study officials:
References:
citation: Alaqzam TS, Stanley AC, Simpson PM, Flood VH, Menon S. Treatment Modalities in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2018 Oct;31(5):451-458. doi: 10.1016/j.jpag.2018.02.130. Epub 2018 Mar 8.
citation: Klebanoff JS, Marfori CQ, Ingraham CF, Wu CZ, Moawad GN. Applications of Tranexamic acid in benign gynecology. Curr Opin Obstet Gynecol. 2019 Aug;31(4):235-239. doi: 10.1097/GCO.0000000000000547.
citation: Franz ND, Machado-Aranda D, Miller JT, Farina N. Impact of Obesity on Tranexamic Acid Efficacy in Adult Patients With Major Bleeding. Ann Pharmacother. 2021 Sep;55(9):1076-1083. doi: 10.1177/1060028020983323. Epub 2020 Dec 31.
citation: Rahman S, Khan FS, Samin KA, Afridi N, Ahmed M. Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding. Cureus. 2021 Oct 29;13(10):e19122. doi: 10.7759/cureus.19122. eCollection 2021 Oct.