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The effect of vitamin B1 on the complications after the insertion of Intra uterin device in women gravid of 1-4

Protocol summary

Summary
The side effects caused by IUD are the main reasons why women avoid using it continously.Pain and bleeding are the main side effects of using copper IUD.The purpose of this controlled random clinical study is to determine the effect of vitamin B1 on the side effects caused by IUD insertion. This double-blinded clinical trial is performed on 110 women aged 18 to 35, gravid of 1-4 being applicant for using IUD refering to 4 clinics in the city between 1390 and 1391. After IUD insertion by the midwife of the clinic, the initial guestionnaire is completed by the surveyor and then within the first month after IUD insertion, she fills her menstruation characteristics in her check list.IF bleeding, menstruation cycle duration, the number of sanitary napkins used, and menstruation pain increase within the first cycle after IUD insertion, she will be chosen as a sample.Then all the selected persons should sign an agreement in order to take part in this experiment.100 mg vitamin B1pill is given to the experimental group and its placebo to the control group for 3 months during the second, third and fourth cycle after IUD insertion.The samples are evaluated considering the pain and bleeding intensity within 5months with intervals of 1 month prior to drug intervention (after IUD insertion) ,3 months after drug intervention, and finally one month later, after finishing intervention (without using drug & placebo).In this study, pain intensity is measured by visual analogue scale and menstrual bleeding by Higham chart.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012073010451N1
Registration date: 2012-12-21, 1391/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-21, 1391/10/01
Registrant information
Name
Azam Jafari
Name of organization / entity
Islamic Azad University,Borujerd Branch
Country
Iran (Islamic Republic of)
Phone
+98 66 2351 8000
Email address
a.jafari@iaub.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Boroujerd Branch
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B1 on the complications after the insertion of Intra uterin device in women gravid of 1-4
Public title
The effect of vitamin B1 on the complications after the insertion of Intra uterin device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: : age18-35; Gravid1-4; being literate; using IUD for the first time; having regular menstruation period between 26-30 days; menstruations bleeding duration between 3-7 days;the number of used sanitary napkins between 10-14 numbers.Exclusion criteria:Existing of any kind of genital system diseases ;Background for kidney stone or any problems; any kind of diagnosed physical and psychological diseases; severe dysmenorea, according to visual analogue scale.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University,Borujerd Branch
Street address
Imam Khomeini university complex, yadegare Imam Ave, Navab Squ, Boroujerd
City
Boroujerd
Postal code
6915136111
Approval date
2012-01-10, 1390/10/20
Ethics committee reference number
107901020

Health conditions studied

1

Description of health condition studied
Persons encountering health services in circumstances related to reproduction
ICD-10 code
z30.1
ICD-10 code description
Insertion of (intrauterine) contraceptive device

Primary outcomes

1

Description
Pain resultant from insertion IUD
Timepoint
Within 5 months with intervals of 1 month before intervention, and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
visual analogue scale

2

Description
bleeding
Timepoint
Within 5 months with intervals of 1 month before intervention, and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
Higham chart.

Secondary outcomes

1

Description
spotting
Timepoint
Within 5 months with intervals of 1 month before intervention, and within 3 months after intervention and 1 month after finishing the intervention.
Method of measurement
Higham chart

Intervention groups

1

Description
100mg edible vitamin B1 pill per day for 3 months
Category
Treatment - Drugs

2

Description
In control group, edible placebo per day for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid kordi health center
Full name of responsible person
peidayesh sedighe-Midwife expert
Street address
Shahid kordi health center, Qaani St.
City
Borujerd

2

Recruitment center
Name of recruitment center
Shahid Ragaee health center
Full name of responsible person
Ataei Masoume-Midwife expert
Street address
Farvardin St. Ayatollah kashani St .
City
Boroujerd

3

Recruitment center
Name of recruitment center
Besat health center
Full name of responsible person
peiryaee Atefe-Midwife expert
Street address
Taleqani St.
City
Boroujerd

4

Recruitment center
Name of recruitment center
Shahid Beheshti health center
Full name of responsible person
Goudarzi Fariba-Midwife expert
Street address
Polelavar, Jafari St.
City
Boroujerd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University,Borujerd Branch
Full name of responsible person
Mahdian Mohamad jafar
Street address
Imam Khomeini university complex, yadegare Imam Ave, Navab Squ, Boroujerd
City
Boroujerd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University,Borujerd Branch
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
Ministry of Health and Treatment
Full name of responsible person
Sayyahi Masoume
Position
Master of Midwifery-Employee
Other areas of specialty/work
Street address
Health and Treatment center, Navab Sq.
City
Boroujerd
Postal code
Phone
+66 2 351 3058
Fax
Email
SAYYAHI724@GMAIL.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University,Borujerd Branch
Full name of responsible person
Jafari Azam
Position
Master of Midwifery,university factulty
Other areas of specialty/work
Street address
Paramedic College, Modares Sq.
City
Boroujerd
Postal code
Phone
+66 2 350 0201
Fax
Email
A.JAFARI@IAUB.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University,Borujerd Branch
Full name of responsible person
Jafari Azam
Position
Master of Midwifery,university factulty
Other areas of specialty/work
Street address
Paramedic College, Modares Sq.
City
Boroujerd
Postal code
Phone
+66 2 350 0201
Fax
Email
a.jafari@iaub.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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