The purpose of this study is determining the effects of Tranexamic acid and Medroxyprogestrone acetate on puerperal bleeding .Inclusion criteria: Puerperal bleeding more than 30 days; dizziness; hypotension. Exclusion criteria: Birth canal lacerations; retained placenta . 66 patients who refer to Imam Reza hospital will evaluate.One group under treatment with transexamic acid and the other group under treatment with medroxy progestrone acetate.6 weeks later they will evaluate for response to treatment; reduce bleeding; Hb level and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306193461N6
Registration date:2013-08-06, 1392/05/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-06, 1392/05/15
Registrant information
Name
Firoozeh Veisi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 4276
Email address
f_veisi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences,Kermanshah, Iran
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparisone of effects of Transexamic acid and Medroxyprogestrone on puerperal bleeding
Public title
The effect of transexamic acid and medroxyprogestrone on puerperal bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: women 15-45 ages with prolonged puerperal bleeding; dizziness; hypotension; skin allergy because of tampone use;and 30 days after delivery.
Exclusion critreias: Birth canal lacerations; retained placenta; myoma and endometrial polyps; history of chronic diseases such as: hepatic, renal,diabetes, thromboembolic and coagulative disorders; anticoagulative drug use ; and thrombocytopenia.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Kermanshah University of Medical Sciences
Street address
Kermanshah,Daneshgah Blv, Parastar Ave.
City
Kermanshah
Postal code
Approval date
2013-02-12, 1391/11/24
Ethics committee reference number
1504
Health conditions studied
1
Description of health condition studied
puerperal bleeding
ICD-10 code
090.9
ICD-10 code description
complications of the the puerperium unspecified
Primary outcomes
1
Description
The volume of bleeding
Timepoint
Before and six weeks after intervention
Method of measurement
The number of used pads before and after intervention
2
Description
Hb level
Timepoint
Before and six weeks after intervention
Method of measurement
Hb level measurement
Secondary outcomes
1
Description
Headache and dizziness
Timepoint
Before and six weeks after intervention
Method of measurement
Patient report
2
Description
Spotting
Timepoint
Before and six weeks after intervention
Method of measurement
Patient report
3
Description
Repeat intervention
Timepoint
Up to six weeks after intervention
Method of measurement
Surgery,D&C,administration of drug
Intervention groups
1
Description
Group A:every 12 hour,250 mg oral transexamic acid capsule with two ferrous sulfate is given.
Category
Treatment - Drugs
2
Description
Group B: every 12 hour 1 tablet 5 mg medroxyprogestrone with two ferrous sulfat is given
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital clinic
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
firoozeh veisi
Street address
Kermanshah, Imam Reza Hospital
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
firoozeh veisi
Position
Assistant professor
Other areas of specialty/work
Street address
Kermanshah ,Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
f_veisi@kums.ac.ir
firoozehveisi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
firoozeh veisi
Position
Assistant professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
f_veisi@kums.ac.irfiroozehveisi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
firoozeh veisi
Position
Assistant Professor
Other areas of specialty/work
Street address
Kermanshah, Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
f_veisi@kums.ac.irfiroozehveisi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)