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.: PACTR201610001803327 Date of Approval: 03/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postpartum hemorrhage
Official scientific title Bilateral uterine artery ligation and square sutures versus a novel combined suture for controlling bleeding from the placental bed in placenta previa centralis at cesarean section: a randomized clinical trial
Brief summary describing the background and objectives of the trial Bilateral uterine artery ligation and square sutures versus a novel combined suture for controlling bleeding from the placental bed in placenta previa centralis at cesarean section
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Postpartum hemorrhage, cesarean section,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 16/10/2016
Actual trial start date 14/10/2016
Anticipated date of last follow up 16/06/2017
Actual Last follow-up date 08/05/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral uterine artery ligation and square sutures surgical procedure surgical procedure surgical procedure 50
Experimental Group novel combined suture surgical procedure surgical procedure surgical procedure 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
100 patients with primary Postpartum hemorrhage (PPH) from the placental bed in cases of placenta previa centralis during cesarean section Patients with placenta accreta at cesarean section diagnosed on clinical basis (difficult removal of the placenta and excessive maternal hemorrhage) were excluded. 20 Year(s) 34 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 12/09/2016 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy of the procedure (defined as arrest of bleeding with no need for further interventions). Efficacy of the procedure (defined as arrest of bleeding with no need for further interventions).
Secondary Outcome duration of the procedure and adverse effects. duration of the procedure and adverse effects.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafrmanawahla El-Bajour 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
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