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.: PACTR201701001984391 Date of Approval: 18/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of cervical traction on uterine artery doppler
Official scientific title Uterine artery hemodynamic changes due to Amr¿s maneuver (Cervical Traction); randomized controlled trial
Brief summary describing the background and objectives of the trial cervical traction for 90 seconds may control post partum hemorrhage by kinking uterine vessels and decrease blood flow
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 01/03/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Amr maneuver cervical traction 90seconds cervical traction 30
Control Group no traction observation 90seconds no traction 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
vaginal delivery of mature fetus CS, DIC 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
No 25/01/2017 CUH ethical committee
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 doppler indices at end of cervical traction
Secondary Outcome post partum hemorrhage at end of 90 second
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CUH kasralainy st Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH kasralainy st Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH kasralainy st Cairo 11555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Awad 9saidzulfakar Cairo 11555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 01111765934 24abderahman elbarkoky
City Postal code Country Position/Affiliation
Cairo 11555 El Salvador Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Awda m_oj_h@yahoo.com 01005034393 9saidzulfakar
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Amr Hamdy hamdyamr2014@gmail.com 00201002412862 Maadi, Al-Horya Square
City Postal code Country Position/Affiliation
Cairo 11742 Egypt National Researches Center
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