Comparison between the efficacy of Mefenamic acid and Tranxamic acid in control of menorrhagia in IUD users in coverage area of Shahid Beheshti University
Objective: To compare the effects of mefenamic acid and tranexamic acid in menorrhagia among IUD users who attending to the health care centers of shahid Beheshti University of medical sciense from April 2012 to December 2013.
Design: Single blind prospective clinical trial.
Populations: 450 women who attending in urban health care centers of the shahid beheshti University of medical sciense.
Inclusion criteria؛ Patients should be eligible for IUD insertion accordance to state protocol؛ These patients had regular menstural bleeding before and after IUD insertion؛They had long menstrual bleeding more than 7 days and their menstural volume were greater than 80 cc.
Exclusion criteria؛ Patients who had anatomical abnormalities such as uterine myoma and adenomyosis؛ Coagulopathies؛ Anticoagulant therapy and genital infection and endometritis and other confounding factors can lead to excesive bleeding.
Intervention: The first group take as two 250 mg capsules of Mefenamic Acid three times a day and the second group take 500 mg Tranexamic acid tablets or capsules three times a day.
Time of intervention: The intervention took three months for using drugs during hemorrhage.
Primary outcome measure: Determine the volume of blood loss,and day numbers , and sequence of bleeding.
Secondary outcome measures: Hemoglobin and hematocrit concentration on admission and at the end of the treatment.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015012612494N3
Registration date:2015-03-04, 1393/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-04, 1393/12/13
Registrant information
Name
Nasrin Saharkhiz
Name of organization / entity
Infertility & Reproductive Health Research Centre of SHahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
saharkhiz.n@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Expected recruitment start date
2012-07-01, 1391/04/11
Expected recruitment end date
2013-11-02, 1392/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy of Mefenamic acid and Tranxamic acid in control of menorrhagia in IUD users in coverage area of Shahid Beheshti University
Public title
Comparison between two drugs, Mefenamic acid and Tranxamic acid for the treatment of menorrhagia due to IUD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria؛ Patients should be eligible for IUD insertion accordance to state protocol؛ And after IUD insertion؛ they have long more than 7 days of menstrual bleeding and menstural volume are greater than 80 cc.
Exclusion criteria؛ Patients with anatomical abnormalities such as uterine myoma and adenomyosis؛ coagulopathies؛ anticoagulant therapy and genital infection and endometritis and other confounding factors can lead to increased bleeding.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
450
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of