Assessing the priming effect of Hyoscine instillation on the unripe cervix of
the nonpregnant women
Design
In this research, 30 eligible women who are candidates for intrauterine procedure and have closed cervix in primary examination are chosen and
the intervention is done without randomization and control group.
Settings and conduct
Among the office patients, women who are candidate for intrauterine procedure and have a stenotic cervix are chosen and the researcher writes the information related to their primary examination of their cervix. Then she instills their cervix by 20 mg of hyoscin and after 10 minutes she measures
their cervix dilatation with a maximum size dilator device which passes through the cervix hole.
Participants/Inclusion and exclusion criteria
Patients who are candidates of intrauterine procedure while having closed cervix; people who want to insert IUD for contraception but have a closed cervix are included to the study and people who have heart disease; peaple who take sympathetic stimulating medications; patients with hyperthyroidism; women who are allergic to Hyoscine are not included.
Intervention groups
patients, who are candidates of intrauterine procedure and have a closed cervix in their primary examination, are chosen and before the procedure, 20 mg of Hyoscine solution is poured on their cervix ostium and the size of cervical os reassessed after 10 minutes.
Main outcome variables
uterine cervix opening size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130119012190N6
Registration date:2018-01-26, 1396/11/06
Registration timing:registered_while_recruiting
Last update:2018-01-26, 1396/11/06
Update count:0
Registration date
2018-01-26, 1396/11/06
Registrant information
Name
Shiva Hadadian
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
shivahadadian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-04-03, 1397/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the priming effect of Hyoscine instillation on the cervix of married women aged 20-70.
Public title
Priming of the uterine cervix by Hyoscine instillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who are candidate for intrauterine procedure
having closed cervix in primary examinnation
Exclusion criteria:
Heart disease
Taking anticholinergic drugs
Allergy to Hyoscin
Hyperthyroidism
Age
From 20 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Beheshti University of Medical Science
Street address
Next to Ayatollah Taleghani Hospital, Yaman Street, Evin, Shahid Chamran High way, Tehran
City
Tehran
Province
Tehran
Postal code
198396-3113
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.623
Health conditions studied
1
Description of health condition studied
closed cervix of the uterine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
uterine cervix opening diameter
Timepoint
At the beginning of the study and ten minutes later.
Method of measurement
Dilator with maximum size
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Non pregnant women who are candidate of intrauterine procedure and they have a closed uterine cervix in examination are instilled in the cervix by 20 mg of Hyoscin, produced by Toliddaru company, which is an anticholinergic drug with anti spasm effect.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gharazi hospital
Full name of responsible person
Shiva Hadadian
Street address
Gharazi hospital, Shafa St., Malek Ashtar Blvd.
City
Sirjan
Province
Kerman
Postal code
7817831151
Phone
+98 34 4142 2200
Email
shivahadadian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani hospital, Yaman street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 23871
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shiva Hadadian
Position
gynecologist and obstetrician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.4, Ramezani St., Poonak Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1469653573
Phone
+98 21 4447 6473
Fax
Email
shivahadadian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shiva Hadadian
Position
gynecologist and obstetrician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.4, Ramezani St., Poonak Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1469653573
Phone
+98 21 4447 6473
Fax
Email
shivahadadian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shiva Hadadian
Position
gynecologist and obstetrician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.4, Ramezani St., Poonak Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1469653573
Phone
+98 21 4447 6473
Fax
Email
shivahadadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data related to participants of the study are shareable after hiding their identities. Also protocol of study, study results, informed consent and statistical analysis plan are shareable.
When the data will become available and for how long
one month after announcing the results of study
To whom data/document is available
Academic people
Under which criteria data/document could be used
doing drug researches
From where data/document is obtainable
shivahadadian@yahoo.com
Shiva Hadadian
What processes are involved for a request to access data/document
After expressing the purpose of needing the data via email and sending a letter showing that the they are used for scientific purposes, the data would be sent in one month.