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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.
Scientific title
Puerperal and menstrual bleeding patterns after two types of contraceptive devices fitted during elective cesarean section.
Secondary ID [1] 262984 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
contraception 270707 0
Condition category
Condition code
Reproductive Health and Childbirth 270885 270885 0 0
Contraception
Surgery 270929 270929 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269327 0
Treatment: Devices
Comparator / control treatment
Cesarean section without device insertion.
Control group
Active

Outcomes
Primary outcome [1] 279564 0
peurperal blood loss measurement using suction set during operation and pad weighing thereafter.
Timepoint [1] 279564 0
40 days after delivery
Secondary outcome [1] 287903 0
menstrual blood loss using self-reported menstrual diary.
Timepoint [1] 287903 0
1 year after delivery

Eligibility
Key inclusion criteria
healthy women, with full-term pregnancy, undergoing elective cesarean delivery, with no medical problems, normal uterus.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
labor pains, multiple pregnancy, medical problems, uterine pathology.

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



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/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] 3824 0
Egypt
State/province [1] 3824 0

Funding & Sponsors
Funding source category [1] 269801 0
Self funded/Unfunded
Name [1] 269801 0
Mervat Sheikh Elarab Elsedeek Omran
Address [1] 269801 0
649 Elhoreya street, alexandria, Egypt, 03312
Country [1] 269801 0
Egypt
Primary sponsor type
Individual
Name
Mervat Sheikh Elarab Elsedeek Omran
Address
649 Elhoreya street, alexandria, Egypt, 03312
Country
Egypt
Secondary sponsor category [1] 268836 0
University
Name [1] 268836 0
Alexandria faculty of Medicine, Alexandria University
Address [1] 268836 0
Alexandria faculty of Medicine, Alexandria University, Elraml station, Alexandria, Egypt, 03312.
Country [1] 268836 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271765 0
The ethics committe of Alexandria faculty of medicine, Alexandria university.
Ethics committee address [1] 271765 0
Alexandria faculty of Medicine, Elraml station, Alexandria, Egypt, 03312.
Ethics committee country [1] 271765 0
Egypt
Date submitted for ethics approval [1] 271765 0
Approval date [1] 271765 0
20/12/2006
Ethics approval number [1] 271765 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33113 0
Address 33113 0
Country 33113 0
Phone 33113 0
Fax 33113 0
Email 33113 0
Contact person for public queries
Name 16360 0
Mervat Sheikh elarab Elsedeek
Address 16360 0
649 Elhoreya street, Janaklis, Alexandria,Egypt, 03312
Country 16360 0
Egypt
Phone 16360 0
00203 5759925
Fax 16360 0
00203 4832363
Email 16360 0
mervatsheikhelarab@yahoo.com
Contact person for scientific queries
Name 7288 0
Mervat Sheikh elarab Elsedeek
Address 7288 0
649 Elhoreya street, Janaklis, Alexandria,Egypt, 03312
Country 7288 0
Egypt
Phone 7288 0
00203 5759925
Fax 7288 0
00203 4832363
Email 7288 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