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Trial registered on ANZCTR


Registration number
ACTRN12611000638932
Ethics application status
Approved
Date submitted
18/06/2011
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of pre-operative misoprostol on blood loss during and after elective cesarean delivery.
Scientific title
Impact of pre-operative misoprostol on blood loss during and after elective cesarean delivery.
Secondary ID [1] 262399 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood loss during and after cesarean delivery 268105 0
Condition category
Condition code
Reproductive Health and Childbirth 268248 268248 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
preoperative adminstration of 400 microgram rectal misoprostol immediately before skin incision.
Intervention code [1] 266788 0
Treatment: Drugs
Intervention code [2] 266801 0
Prevention
Comparator / control treatment
there is control group receiving the standard care which means starting oxytocin infusion in the rate of 340miu/min. after cord clamping.
Control group
Active

Outcomes
Primary outcome [1] 268976 0
Amount of blood loss during cesarean delivery assessed by graduated suction machine .
Timepoint [1] 268976 0
During the operation
Primary outcome [2] 268989 0
Amount of post-partum blood loss during first 24 hours after delivery by pad weighing.
Timepoint [2] 268989 0
within 24 hours of delivery.
Secondary outcome [1] 276738 0
Difference in hematocrit between pre and post-operative values.
Timepoint [1] 276738 0
24 hours after delivery.
Secondary outcome [2] 276759 0
Apgar score of the neonate.
Timepoint [2] 276759 0
1 and 5 minutes after delivery

Eligibility
Key inclusion criteria
elective cesarean, full-term pregnancy, normal blood indices, non-compromised average weight fetus.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
labour pains, multiple pregnancy, bleeding disorder or thrombophilia, abnormal placenta(previa or accreta by ultrasound, fetal distress, preterm fetus.

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 program, sealed envelopes, opened in theater.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
counseling of all eligible women, informed consent then randomization using computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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] 3630 0
Egypt
State/province [1] 3630 0

Funding & Sponsors
Funding source category [1] 267260 0
Self funded/Unfunded
Name [1] 267260 0
Mervat Sheikh Elarab Elsedeek Omran
Address [1] 267260 0
649 Elhoreya street Janaclis, Elraml district, Alexandria, Egypt.
post code 03312
Country [1] 267260 0
Egypt
Primary sponsor type
Individual
Name
Mervat Sheikh Elarab Elsedeek Omran
Address
49 Elhoreya street Janaclis, Elraml district, Alexandria, Egypt.
post code 03312
Country
Egypt
Secondary sponsor category [1] 266322 0
None
Name [1] 266322 0
Address [1] 266322 0
Country [1] 266322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269253 0
The ethics committee of Alexandria faculty of medicine, Alexandria university.
Ethics committee address [1] 269253 0
Alexandria faculty of medicine, Alexandria university, Alexandria, Egypt.
post code 03312
Ethics committee country [1] 269253 0
Egypt
Date submitted for ethics approval [1] 269253 0
Approval date [1] 269253 0
29/05/2007
Ethics approval number [1] 269253 0

Summary
Brief summary
The primary purpose of this study was to evaluate the efficacy of rectal misoprostol in reducing blood loss during and after cesarean delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32754 0
Address 32754 0
Country 32754 0
Phone 32754 0
Fax 32754 0
Email 32754 0
Contact person for public queries
Name 16001 0
Mervat Sheikh elarab Elsedeek
Address 16001 0
649 elhoreya street, Janaclis, Elraml District, Alexandria, Egypt.
post code 03312
Country 16001 0
Egypt
Phone 16001 0
+203 5759915
Fax 16001 0
Email 16001 0
mervatsheikhelarab@yahoo.com
Contact person for scientific queries
Name 6929 0
Mervat Sheikh elarab Elsedeek
Address 6929 0
649 elhoreya street, Janaclis, Elraml District, Alexandria, Egypt.
post code 03312
Country 6929 0
Egypt
Phone 6929 0
+203 5759915
Fax 6929 0
Email 6929 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