Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002795139 Date of Approval: 22/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Longitudinal versus transverse extension of uterine incision during cesarean section: randomized controlled trial
Official scientific title Longitudinal versus transverse extension of uterine incision during cesarean section: randomized controlled trial
Brief summary describing the background and objectives of the trial To compare between longitudinal and transverse extension of uterine incision during cesarean section as regard postoperative drop In hemoglobin level, need for blood transfusion, extension of the incision to injure the uterine artery, additional stitches needed to close the incision
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Extension of uterine incision,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 01/04/2018
Anticipated target sample size (number of participants) 392
Actual target sample size (number of participants) 392
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomized table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Longitudinal extension Uterine incision extended longitudinally 196
Experimental Group Transverse extension Uterine incision extended transversely 196
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18 or more. Term pregnancy. Elective previous one cesarean section Any previous uterine scar other than CS or more than one previous CS Multiple pregnancy Malpresentation Antepartum hemorrhage Fetal macrosomia Polyhydramnios Any participation in another trial that interferes with this trial. 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/11/2017 Airforce specialized Hospital
Ethics Committee Address
Street address City Postal code Country
Elteseen (ninety ) street Cairo Not available Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Unintended extension of the Uterine incision During operation
Secondary Outcome Number of additional stitches needed During the iperation
Secondary Outcome Drop of hemoglobin level By measuring the difference between pre & postoperative hemoglobin
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
October 6th University Central axis Giza Not available Egypt
Airforce specialized Hospital Elteseen (ninety street) Cairo Not available Egypt
Algalaa teaching hospital Algalaa street- Downtown Cairo Not avail Egypt
AlAzhar University hospital Downtown Cairo unavailab Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Airforce specialized Hospital Elteseen (ninety) street Cairo Not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Airforce specialized Hospital Elteseen ( ninety) street Cairo Not available Egypt Hospital
Primary Sponsor October 6th University Central axis Giza Not available Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Sherif Abassiya Cairo Not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Ahmed Sherif ahmedgyna@yahoo.com +201227960980 Abassiya
City Postal code Country Position/Affiliation
Cairo Not available Egypt Aim-Shams University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information