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Trial registered on ANZCTR
Registration number
ACTRN12611000983909
Ethics application status
Approved
Date submitted
6/09/2011
Date registered
15/09/2011
Date last updated
15/09/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Puerperal and menstrual bleeding patterns after two types of contraceptive devices fitted during elective cesarean section.
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Scientific title
Puerperal and menstrual bleeding patterns after two types of contraceptive devices fitted during elective cesarean section.
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Secondary ID [1]
262984
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
contraception
270707
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Condition category
Condition code
Reproductive Health and Childbirth
270885
270885
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0
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Contraception
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Surgery
270929
270929
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
There are a total of three groups in this study (a) Copper containing intra-uterine contraceptive device (IUCD) inserted during cesarean section (C.S.) for future contraception, (b) Levonorgestrel containing device inserted for the same indication and (c) Cesarean section without device insertion. Copper containing contraceptive device is the standard IUD used for birth control while Levonorgestrel containing intra-uterine system (IUS) is a newer intrauterine contraceptive device with a steroid reservoir that releases 20 micrograms of levonorgestrel daily. Insertion during cesarean section, requires one minute to perform to be removed on patient request or after expiry of the device (5 years for levonorgestrel device, and 10 years for IUCD), however the duration of follow-up in the study is only 18 months.
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Intervention code [1]
269327
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Treatment: Devices
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Comparator / control treatment
Cesarean section without device insertion.
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Control group
Active
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Outcomes
Primary outcome [1]
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peurperal blood loss measurement using suction set during operation and pad weighing thereafter.
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Assessment method [1]
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Timepoint [1]
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40 days after delivery
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Secondary outcome [1]
287903
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menstrual blood loss using self-reported menstrual diary.
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Assessment method [1]
287903
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Timepoint [1]
287903
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1 year after delivery
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Eligibility
Key inclusion criteria
healthy women, with full-term pregnancy, undergoing elective cesarean delivery, with no medical problems, normal uterus.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
labor pains, multiple pregnancy, medical problems, uterine pathology.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3824
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Egypt
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State/province [1]
3824
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Funding & Sponsors
Funding source category [1]
269801
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Self funded/Unfunded
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Name [1]
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Mervat Sheikh Elarab Elsedeek Omran
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Address [1]
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649 Elhoreya street, alexandria, Egypt, 03312
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Country [1]
269801
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Egypt
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Primary sponsor type
Individual
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Name
Mervat Sheikh Elarab Elsedeek Omran
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Address
649 Elhoreya street, alexandria, Egypt, 03312
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Country
Egypt
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Secondary sponsor category [1]
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University
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Name [1]
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Alexandria faculty of Medicine, Alexandria University
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Address [1]
268836
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Alexandria faculty of Medicine, Alexandria University, Elraml station, Alexandria, Egypt, 03312.
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Country [1]
268836
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Egypt
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The ethics committe of Alexandria faculty of medicine, Alexandria university.
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Ethics committee address [1]
271765
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Alexandria faculty of Medicine, Elraml station, Alexandria, Egypt, 03312.
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Ethics committee country [1]
271765
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Egypt
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Date submitted for ethics approval [1]
271765
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Approval date [1]
271765
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20/12/2006
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Ethics approval number [1]
271765
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Summary
Brief summary
to test the feasibility, safety, and efficacy of contraceptive devices fitting during elective cesarean delivery as well as the impact of this intervention on peurperal and menstrual blood loss.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
33113
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Country
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Phone
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Fax
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Email
33113
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Contact person for public queries
Name
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Mervat Sheikh elarab Elsedeek
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Address
16360
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649 Elhoreya street, Janaklis, Alexandria,Egypt, 03312
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Country
16360
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Egypt
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Phone
16360
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00203 5759925
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Fax
16360
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00203 4832363
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Email
16360
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[email protected]
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Contact person for scientific queries
Name
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Mervat Sheikh elarab Elsedeek
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Address
7288
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649 Elhoreya street, Janaklis, Alexandria,Egypt, 03312
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Country
7288
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Egypt
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Phone
7288
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00203 5759925
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Fax
7288
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00203 4832363
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Email
7288
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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