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Comparison of the effect of vaginal Misoprostol and vaginal Isoniazid for cervical ripening prior to hysteroscopy procedures in postmenopausal and premenopausal women: Randomized Clinical Trial

Protocol summary

Summary
The aim of this clinical trial study is to compare the efficacy of vaginal misoprostol and isoniazid for cervical ripening prior to hysteroscopy surgery. Inclusion criteria: postmenopausal women and premenopausal women who have no history of vaginal delivery, not pregnant at the time of examination, no contraindication for receiving prostaglandin, no severe vaginal prolapse , no previous surgery on cervix or cervical incompetence. Exclusion criteria: history of vaginal delivery, pregnancy, severe vaginal prolapse, previous surgery on cervix, history of cervical insufficiency, simultaneous laparoscopy and cervical myoma. After confirming the inclusion criteria and obtaining the written informed consent, they randomly assigned to one of two groups, either receiving 400 micrograms of misoprostol vaginally or 3 tablets of 300 mg isoniazid 10-12 hours before operation. The way of randomization into two groups, randomly using Excel software for it. Also to blinding of patients and researchers, used of hide the sealed envelopes. The primary outcomes of the study is interring the hysteroscopy without cervical dilation, and secondary outcomes are number and percentage of patients requiring cervical dilatation, maximum Hagar size interring without force and the side effects. Eventually these outcomes compare in two groups. The sample size in each group is 50 people.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112821506N4
Registration date: 2016-05-17, 1395/02/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-17, 1395/02/28
Registrant information
Name
Ladan Haghighi
Name of organization / entity
Iran Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 64345
Email address
haghighi.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vaginal Misoprostol and vaginal Isoniazid for cervical ripening prior to hysteroscopy procedures in postmenopausal and premenopausal women: Randomized Clinical Trial
Public title
Comparison the effect of vaginal Misoprostol and vaginal Isoniazid for cervical ripening prior to hysteroscopy procedures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: postmenopausal women and premenopausal women who have no history of vaginal delivery, not pregnant at the time of examination, no contraindication for receiving prostaglandin , no severe vaginal prolapse , no previous surgery on cervix or cervical incompetence. Exclusion criteria: history of vaginal delivery, pregnancy, severe vaginal prolapse, previous surgery on cervix, history of cervical insufficiency, simultaneous laparoscopy and cervical myoma.
Age
From 15 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
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 Iran University of Medical Science
Street address
Iran, Tehran, Hemat Highway, Milad Tower
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.IUMS.REC.1394 .26541

Health conditions studied

1

Description of health condition studied
Abnormal uterine and vaginal bleeding, unspecified
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified

Primary outcomes

1

Description
Hysteroscopy entrance without cervical dilatation
Timepoint
During surgery
Method of measurement
Hagar size

Secondary outcomes

1

Description
The number and percent of patients needs for cervical dilatation
Timepoint
During surgery
Method of measurement
Counting

2

Description
Maximum Hagar size interring without forces
Timepoint
During surgery
Method of measurement
Hagar

Intervention groups

1

Description
Intervention group: 12-10 hours prior to surgery, the use of vaginal misoprostol much as 400 micrograms
Category
Diagnosis

2

Description
Control group: 12-10 hours before the operation, taking 3 tablets of 300 mg isoniazid vaginal
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram hospital
Full name of responsible person
Dr. Ladan Haghighi
Street address
Niayesh Av, Sattar khan st, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Musavi
Street address
Vice chancellor for research, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Science
Full name of responsible person
Ladan Haghighi
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av, Sattar khan St, Tehran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
dr.ladanhaghighi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Ladan Haghighi
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av, Sattar khan St, Tehran.
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
Email
dr.ladanhaghighi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Ladan Haghighi
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av, Sattar khan St, Tehran.
City
Tehran
Postal code
Phone
+98 21 6650 9283
Fax
Email
dr.ladanhaghighi@yahoo.com
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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