The purpose of the present study is to evaluate the effect of vaginal misoprostol on priming the cervix before dilatation in patients who are candidate for this procedure.
Methods : A vandomized clinical trial was performed on 60 women who were candidated for dilation and curretage . In 30 patients ( case group), 200micro gram misoprostol ( one tablet ) was administered in posterior fornix of vagina 4 hours before operation , whereas in other 30 patients ( control group ), placebo was used. Then the two groups were compared according to their need to Hegar dilatator thinner than number 5 for dilatation of cervix and the duration of dilatation and curettage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110084868N3
Registration date:2011-12-20, 1390/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Khadijeh Elmizadeh
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 6001
Email address
khelmizadeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research , Qazvin university of medical sciences and heaith services
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal misoprostol on cervical priming ic diagnostic dilatation and curettage
Public title
use of vaginal misoprostol for cervical ripening
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :patints with abnormal uterine bleeding who are candidate for dilation and curretage
exclusion criteria :systemic diseases ; cervical and vaginal infections; history of allergy to prostaglandins ; sever anemia or coagulopathy; anticoagulant therapy; history of cervical surgery;pregnancy; lactation; menopause; suspicious endocervical or exocervical erosions;
Age
From 27 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin , university of medical scienes and health servies
Street address
Qazvin
City
Qazvin
Postal code
Approval date
2010-09-22, 1389/06/31
Ethics committee reference number
28/20/4418
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N92
ICD-10 code description
Excessive, frequent and irregular menstruation
Primary outcomes
1
Description
dilation of cervix as much as hegar dilator numbr five
Timepoint
four hour after using drug
Method of measurement
passage of hegar dilator numbr five
Secondary outcomes
1
Description
Decrease in operation time
Timepoint
During operation
Method of measurement
Measurement with chronometer
Intervention groups
1
Description
Intervention:30paitents misoprostol one tablet(200 micro gr)was inserted in the vagina 4 hours before surjery for one time.
Category
Treatment - Other
2
Description
Control :In 30paisents one placebo tablet was inserted in vagina 4hours befor surjery for one time.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Haspital
Full name of responsible person
Dr Khadijeh Elmizadeh
Street address
, Taleghni stereet , Kosar Hospital, Qazvin City
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice- chancellor for research , Qazvin univercity of medical sciences and health services
Full name of responsible person
Dr Saeed Asefzadeh
Street address
Shahid Bahonar Blv , Qazvin City
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice- chancellor for research , Qazvin univercity of medical sciences and health services
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
Qazvin , university of medical sciences and health services
Full name of responsible person
Dr Khadijeh Elmizadeh
Position
Obstetrician and Ghynecologist
Other areas of specialty/work
Street address
Taleghani Street , Kosar Haspital , Qazvin City
City
Qazvin
Postal code
Phone
+98 28 1334 7280
Fax
+98 28 1223 6378
Email
khelmizadeh@quma.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin , university of medical sciences and health services
Full name of responsible person
Dr Khadijeh Elmizadeh
Position
Obestetrician and Ghynecologist
Other areas of specialty/work
Street address
Taleghani street , Kosar Haspital , Qazvin City
City
Qazvin
Postal code
Phone
+98 28 1334 7280
Fax
Email
khelmizadeh@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin , university of medical sciences and health services
Full name of responsible person
Dr Khadijeh Elmizadeh
Position
Obstetrician and Ghyenecologist
Other areas of specialty/work
Street address
Taleghani Street , Kosar Haspital ,Qazvin City
City
Qazvin
Postal code
43256178671
Phone
+98 28 1334 7280
Fax
Email
khelmizadeh@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)