Evaluation of mizoprostol tablet and mefenamic acid capsule's effect on reducing menstrual bleeding in patients suffering from menorrhagia in Imam Khomeini hospital in 2014.
For evaluating the efficacy of misoprostol and mefenamic acid in reducing menorrhagia volume in patients suffering from heavy menstrual bleeding, this double-blinded randomized clinical trial is designed. Patients with subjective complaint of menorrhagia enter the study and they will be excluded if there is any pelvic or systemic pathology present. patients are randomly grouped into two groups. Blood loss volume is assessed in the first menstrual period and during next period, treatment regimen is started. Treatment outcome in next period will be compared with the previous one. Treatment regimens are Mefenamic acid 250 mg capsule three times a day for a group and misoprostol 200 µg three times a day. Treatment goes on for 3 days. The main assessment parameters are blood loss volume which is measured by pictorial blood assessment chart (PBAC) and dysmenorrheal severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040912790N2
Registration date:2014-07-12, 1393/04/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-12, 1393/04/21
Registrant information
Name
Tahereh Eftekhar
Name of organization / entity
Valie-Asr Repductive Health Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
eftekhart@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences - Vice chancellor for research
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of mizoprostol tablet and mefenamic acid capsule's effect on reducing menstrual bleeding in patients suffering from menorrhagia in Imam Khomeini hospital in 2014.
Public title
Evaluation of mizoprostol tablet and mefenamic acid capsule's effect on reducing menstrual bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
* Inclusion criteria:
women with chief complaint of menorrhagia admitted to the clinic
* Exclusion criteria:
Presence of contraindications to medications
Inability to using medications
Presence of ovarian masses or endometrial hyperplasia
Presence of systemic disorders such as cardio vascular, hepatic or metabolic diseases.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th Floor , Tehran University of Medical Sciences, Qods Street , Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
91/د/2357/ 130
Health conditions studied
1
Description of health condition studied
Menorrhagia
ICD-10 code
N92
ICD-10 code description
Excessive, frequent and irregular menstruation
Primary outcomes
1
Description
Blood loss
Timepoint
First menstruation period - Second Menstruation period
Method of measurement
pictorial blood assesment charts (PBAC)
Secondary outcomes
1
Description
Hemoglobin
Timepoint
First menstrual period - Second menstrual period
Method of measurement
Lab test (gr/dL)
2
Description
dysmenorrhea
Timepoint
First menstrual period - Second menstrual period
Method of measurement
Asking patient (Score 1-10)
3
Description
clot discharge
Timepoint
First menstrual period - Second menstrual period
Method of measurement
Asking patient (Yes/No)
Intervention groups
1
Description
Blood loss is calculated after first menstrual period. Then misoprostol tablet is prescribed for patients so that after second menstrual period, 3 misoprostol 200 µg tablets are used for 3 days. PBAC is used for assessing amount of blood loss.
Category
Treatment - Drugs
2
Description
Blood loss is calculated after first menstrual period. Then mefenamic acid capsule is prescribed for patients so that after second menstrual period, 3 mefenamic acid 250mg capsules are used for 3 days. PBAC is used for assessing amount of blood loss.