Randlist software used to divide patients into 6 groups randomly. 100 mcg sublingual misoprostol in group one, 100 mcg rectal misoprostol in second group and 100 mcg vaginal misoprostol in third group were taken. 200 mcg sublingual misoprostol in fourth group, 200 mcg rectal misoprostol in fifth group and 200 mcg vaginal misoprostol in sixth group were taken. 12 hours before hysteroscopy be placed in posterior vaginal fornix.
Cervix dilation start in Lithotomy position of 4 hegar dilator before hysteroscopy until first resistance. Dilator number recorded in first resistance and duration between first resistance to hegar 9 dilation recorded. Then hysteroscopy was done and start and end time recorded. Hysteroscopy done with hystroscope with 7mm pod or resectoscope with 9mm external pod. Factors are examined include degree of cervical dilatation before hysteroscopy, dilatation to 9 Hegar length and duration of hysteroscopy, uterine and cervical complications (like bleeding, uterine rupture, cervical laceration and false).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105296626N1
Registration date:2011-07-26, 1390/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-26, 1390/05/04
Registrant information
Name
Seddighe Abdollahi fard
Name of organization / entity
Tabriz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 4250
Email address
dr-abdollahi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2011-04-07, 1390/01/18
Expected recruitment end date
2011-09-06, 1390/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on compare of sublingual, rectal and vaginal misoprostol for cervical priming 12 hours before hysteroscopy
Public title
Study on compare of sublingual, rectal and vaginal misoprostol for cervical priming 12 hours before hysteroscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All the patients who need diagnostic hysteroscopy and surgery such as: irregular uteral bleeding; inter uteral lesions in hysterosalpangography or sonography.
Exclusion criteria: pregnancy; urinary tract infection; history of previous cervix surgery; cervix failure; patient dissatisfaction and prohibition prostaglandin intake
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Azadi ave, Golgasht ave, Tabriz University of Medical Science
City
Tabriz
Postal code
Approval date
2011-04-06, 1390/01/17
Ethics committee reference number
5/4/321
Health conditions studied
1
Description of health condition studied
Patients who are candidates for hysteroscopy
ICD-10 code
N85.9
ICD-10 code description
Noninflammatory disorder of uterus, unspecified
2
Description of health condition studied
Patients who are candidates for hysteroscopy
ICD-10 code
N71.9
ICD-10 code description
Inflammatory disease of uterus, unspecified
Primary outcomes
1
Description
Cervix dilation for hysteroscopy
Timepoint
During hysteroscopy
Method of measurement
Hegar
Secondary outcomes
1
Description
Reduce hysteroscopy's complications
Timepoint
After hysteroscopy
Method of measurement
By examination
2
Description
Reduce pain during hysteroscopy
Timepoint
During hysteroscopy
Method of measurement
Ask from patient
Intervention groups
1
Description
100 mcg sublingual misoprostol 12 hours before hysteroscopy,
Category
Diagnosis
2
Description
200 mcg sublingual misoprostol 12 hour before hysteroscopy
Category
Diagnosis
3
Description
100 mcg rectal misoprostol 12 hour before hysteroscopy
Category
Diagnosis
4
Description
200 mcg rectal misoprostol 12 hour before hysteroscopy
Category
Diagnosis
5
Description
100 mcg vaginal misoprostol 12 hour before hysteroscopy
Category
Diagnosis
6
Description
200 mcg vaginal misoprostol 12 hour before hysteroscopy
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Zahra hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical science
Full name of responsible person
Vise chanceller research of tabriz university of medical science
Street address
azadi ave, golgasht ave, tabriz university of medical science
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of medical science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science, AL-zahra hospital
Full name of responsible person
Seddighe Abdollahi
Position
Associate Professor
Other areas of specialty/work
Street address
South artesh ave, Bagh shomal crossroad, Al_zahra hospital
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
dr-abdollahi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Paria Sedaghi
Position
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
paria_sedaghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)