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.: PACTR201407000852144 Date of Approval: 13/07/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Trial of labour in comparison to repeat cesarean section
Official scientific title The safety, acceptability and cost-effectiveness of planned vaginal birth after cesarean compared to repeated cesarean section
Brief summary describing the background and objectives of the trial Trial of labour in comparison to repeat cesarean section regarding the maternal & fetal outcome, maternal acceptability and cost-effectiveness
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Trial of labour after cesarean section
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Labour and birth after caesarean section
Anticipated trial start date 01/08/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 01/12/2014
Actual Last follow-up date 25/12/2014
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants) 220
Recruitment status Stopped early/ terminated
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Trial of labour - - Trial of labour after cesarean section 110
Control Group repeated cesarean section - - repeated cesareansection 110
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Previous one cesarean section Contraindications to trial of labour 19 Year(s) 35 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 Faculty of Medicine-Menoufia University
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-elghafar Shibin ElKom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal and fetal outcome Till the end of puerperium
Secondary Outcome Maternal acceptability after delivery
Secondary Outcome Cost-effectiveness At the end of puerperium
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-elghafar Shibin ElKom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-elghafar Shibin ElKom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Rezk Kafr Manawahla Elbajour 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafr Manawahla Elbajour 002048 Egypt
Alaa Masood Mogamaa Shibin ElKom 002048 Egypt
Ragab Dawood Elmahta Quesna 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk mohamed.abdallah1975@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Alaa Masood dralaamasoud75@yahoo.com 00201001545759 Mogamaa
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Ragab Dawood Dr_ragabdawood@yahoo.com 00201003784772 Elmahta
City Postal code Country Position/Affiliation
Quesna 002048 Egypt Lecturer of Obstetrics and Gynecology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information