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Trial registered on ANZCTR


Registration number
ACTRN12615000526572
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
26/05/2015
Date last updated
26/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of the traditional blind technique versus the novel ultrasound guided technique for office fitting of intra-uterine contraceptive devices on success of insertion, time required and patient satisfaction in healthy women with regular menstrual periods
Scientific title
Impact of the traditional blind technique versus the novel ultrasound guided technique for office fitting of intra-uterine contraceptive devices on success of insertion, time required and patient satisfaction in healthy women with regular menstrual periods.
Secondary ID [1] 285999 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility control 293959 0
Condition category
Condition code
Reproductive Health and Childbirth 294256 294256 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intra-uterine contraceptive devices are inserted guided by transabdominal ultrasound with the probe held by an assistant through the procedure which require one to three minutes.
Intervention code [1] 290976 0
Prevention
Intervention code [2] 290977 0
Treatment: Devices
Comparator / control treatment
Intra-uterine contraceptive devices are inserted blindly with trans-vaginal sonography performed before and after the procedure which requires one to five minutes.
Control group
Active

Outcomes
Primary outcome [1] 294053 0
success and ideal position of device as seen by ultrasound.
Timepoint [1] 294053 0
end of the procedure
Primary outcome [2] 294054 0
Time required for procedure using stop watch.
Timepoint [2] 294054 0
end of the procedure
Secondary outcome [1] 312431 0
patient satisfaction using simple non validated questionnaire designed specifically for this study.
Timepoint [1] 312431 0
end of the procedure

Eligibility
Key inclusion criteria
request for contraception, regular menstrual periods, post-menstrual period, normal uterine cavity.
Minimum age
20 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Uterine pathology, amenorrheic women.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
computer tables and closed envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6600 0
Egypt
State/province [1] 6600 0

Funding & Sponsors
Funding source category [1] 290592 0
Self funded/Unfunded
Name [1] 290592 0
Mervat Sheikhelarab Elsedeek
Address [1] 290592 0
649 Elhoreya road Janaklis, Alexandria, Egypt.
03312
Country [1] 290592 0
Egypt
Primary sponsor type
Individual
Name
Mervat Sheikhelarab Elsedeek
Address
Faculty of Medicine, Alexandria university.
649 Elhoreya road Janaklis, Alexandria, Egypt.
03312
Country
Egypt
Secondary sponsor category [1] 289730 0
None
Name [1] 289730 0
Address [1] 289730 0
Country [1] 289730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292228 0
Faculty of medicine, Alexandria University, Ethical review board.
Ethics committee address [1] 292228 0
Alexandria faculty of Medicine, Azarita, Alexandria, Egypt.
03312
Ethics committee country [1] 292228 0
Egypt
Date submitted for ethics approval [1] 292228 0
17/10/2012
Approval date [1] 292228 0
22/11/2012
Ethics approval number [1] 292228 0

Summary
Brief summary
A new method of IUCD fitting using ultrasound guidance is compared to traditional blind method used for application to find out if it is more effective, and less time consuming.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 44626 0
Prof Mervat Sheikhelarab Elsedeek Omran
Address 44626 0
Faculty of Medicine, Alexandria university.
649 Elhoreya road, Janaklis, Alexandria, Egypt.
23312
Country 44626 0
Egypt
Phone 44626 0
+203 5759915
Fax 44626 0
Email 44626 0
mervatsheikhelarab@yahoo.com
Contact person for public queries
Name 44627 0
Prof Mervat Sheikhelarab Elsedeek Omran
Address 44627 0
Faculty of Medicine, Alexandria university.
649 Elhoreya road, Janaklis, Alexandria, Egypt.
23312
Country 44627 0
Egypt
Phone 44627 0
+203 5759915
Fax 44627 0
Email 44627 0
mervatsheikhelarab@yahoo.com
Contact person for scientific queries
Name 44628 0
Prof Mervat Sheikhelarab Elsedeek Omran
Address 44628 0
Faculty of Medicine, Alexandria university.
649 Elhoreya road, Janaklis, Alexandria, Egypt.
23312
Country 44628 0
Egypt
Phone 44628 0
+203 5759915
Fax 44628 0
Email 44628 0
mervatsheikhelarab@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary