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The priming effect of hyoscin on the cervix of non-pregnant married women before intrauterine procedures.

Protocol summary

Summary
: Uterine cervical firmness has been complained as the main barrier that prevents entering the endometrial cavity during the intrauterine procedures in cases such as endometrial curettage . Mechanical dilatation of cervical canal might cause uterine perforation, cervical tearing or incompetent cervix.Objective: In order to solve this problem, the researcher decided to substitute the mechanical intervention with chemical treatment by administration of Hyoscin to patients. Design:Randomized, double blind, placebo controlled, phase 2 trial. Method: Sixty married nonpregnant women, 20-70 years of age, Including criteria: with cervical firmness who are scheduled for intrauterine procedure, because of gynecological diseases and Excluding criteria:they were not on hormonal therapy lately and they are not allergic to Hyoscin or having contraindication of Hyoscin usage will be randomly divided into two groups. Intervention: Group A, as experimental group, receives two doses of Hyoscin and group B, as control group, receives two doses of vitamin B6 in the posterior fornix of vagina (eight hours and two hours before the procedure) and the effects of these two drugs on Main outcome measure variables: dilatation and consistency of cervix will be studied.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121312190N5
Registration date: 2016-01-25, 1394/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-25, 1394/11/05
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
Investigator.
Expected recruitment start date
2015-12-20, 1394/09/29
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The priming effect of hyoscin on the cervix of non-pregnant married women before intrauterine procedures.
Public title
The effect of Hyoscin on the cervix of non-pregnant married women before curettage.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: women with gynecological diseases who were scheduled for curettage; Good general health; Want to participate in the study after it is explained; Increased endometrial thickness in sonography evaluation or irregular endometrial echo in sonographic view; Uterine cervical firmness in examination. Exclusion Criteria: abundant vaginal bleeding; use of hormone replacement therapy lately; history of hypersensitivity to or contraindication of the Hyoscin usage.
Age
From 20 years old to 70 years old
Gender
Female
Phase
2-3
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
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
Postal code
198396-3113
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
Ir.sbmu.sm.rec.1394.82

Health conditions studied

1

Description of health condition studied
Uterine cervical firmness
ICD-10 code
XIV
ICD-10 code description
Diseases of the genitourinary system

Primary outcomes

1

Description
Uterine cervical dilatation
Timepoint
at the beginning of the study , then 2 hours after the second dose of the investigating drug.
Method of measurement
Budgie

2

Description
Uterine cervical consistancy
Timepoint
at the beginning of the study , then 2 hours after the second dose of the investigating drug.
Method of measurement
passing number 2 Currett through uterine cervix and see its resistance

Secondary outcomes

1

Description
Tackykardia
Timepoint
2 hours after the second dose of the drug (at the beginning of the procedure)
Method of measurement
Questionnaire

2

Description
Uterine perforation
Timepoint
when the device passed through the cervical canal
Method of measurement
Examination

3

Description
Tearing of the uterine cervix
Timepoint
when the device passed through the cervical canal
Method of measurement
Examination

4

Description
Mouth dryness
Timepoint
2 hours after the second dose of the drug (at the beginning of the procedure)
Method of measurement
Questionnaire

5

Description
Nausea and vomitting
Timepoint
2 hours after the second dose of the drug (at the beginning of the procedure)
Method of measurement
Questionnaire

Intervention groups

1

Description
Control group: tablet 40 mg Vitamin B 6, vaginal, two doses, 8 hours and 2 hours before the procedure.
Category
Placebo

2

Description
Intervention group:tablet Hyoscin Butyl Bromide 10 mg , first dose 8 hours and the second dose 2 hours before the procedure, vaginally
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sirjan dr Gharazi hospital
Full name of responsible person
dr Shiva Hadadian
Street address
Dr Gharazi hospital, shafa street
City
Sirjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Science.
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani hospital, Yaman street, Shahid Chamran highway
City
Tehran
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, Shahid Beheshti 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
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr Shiva Hadadian
Position
Gynecologist and Obstetrician
Other areas of specialty/work
Street address
Hamila street, Ashrafi Esfahani highway
City
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 Science
Full name of responsible person
Dr Shiva Hadadian
Position
gynecologist and obstetrician
Other areas of specialty/work
Street address
Hamila street, Ashrafi Esfahani highway
City
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 Science
Full name of responsible person
Dr Shiva Hadadian
Position
gynecologist and obstetrician
Other areas of specialty/work
Street address
4, Hamila street, Ashrafi Esfahani highway, Tehran
City
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)
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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