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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001604186 Date of Registration: 24/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Carbetocin versus Rectal Misoprostol for Management of Third Stage of Labor in Women at Low Risk of Postpartum Hemorrhage
Official scientific title Carbetocin versus Rectal Misoprostol for Management of Third Stage of Labor in Women at Low Risk of Postpartum Hemorrhage
Brief summary describing the background and objectives of the trial to compare two common methods of prevention of post partum hemorrhage aiming to detect which of them more effective
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 15/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 500
Recruitment status Not yet recruiting
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 randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Carbetocin one ampoule 100ug/ml single dose iv infusion 250
Control Group misoprostol 400ug single dose rectal tablet 250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
old age 20-40 no obvious risk of PPH previous CS any risk of PPH 20 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 14/04/2016 CUH
Ethics Committee Address
Street address City Postal code Country
Kasralainy Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevention of PPPH 48 hours post partum
Secondary Outcome Hemoglobin post partum 24 hours Post partum
Secondary Outcome need for blood transfusion within 24 hours Post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasralainy Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH Kasralainy Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH Kasralainy Cairo 11555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Nabil 160 King Faisal Giza 11612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com +201111765934 24 abderahman albarkoky
City Postal code Country Position/Affiliation
Cairo 11451 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mostafa Abdelbar drmostafaabdo@yahoo.com +201002412549 116 tahrir
City Postal code Country Position/Affiliation
Giza Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hala Nabil fawzy.jana@yahoo.com +201002412549 160 Kingfaisal
City Postal code Country Position/Affiliation
Giza Egypt Cairo 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