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.: PACTR201710002653297 Date of Approval: 30/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of early administration of low dose aspirin therapy in obese pregnant women on miscarriage rate and uterine artery Doppler indices .
Official scientific title Effect of early administration of low dose aspirin therapy in obese pregnant women on miscarriage rate and uterine artery Doppler indices . Randomized controlled trial
Brief summary describing the background and objectives of the trial we will study effect of low dose aspirin on abortion rate and uterine doppler in pregnant obese females
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2018
Anticipated date of last follow up 01/10/2018
Actual Last follow-up date 01/10/2018
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
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 Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group low dose aspirin 75mg perday 20 weeks low dose aspirin 200
Control Group placebo starch tab 20weeks placebo 200 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 20-40 single tone obese no comorbidity multiple pregnancy comorbidity none obese 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 11/11/2017 CUH ethical committee
Ethics Committee Address
Street address City Postal code Country
kasralainy st Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome abortion rate 20 week
Secondary Outcome doppler of uterine artery 20weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital kasralainy st Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university 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
M H Awad 9 zulfakar st Cairo 11555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 01111765934 4A-19 division 3 zahraa almaady
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Ibtisam Zeefan e_kamal_84520@yahoo.com : 01110768812 almanyal st
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohammed Awad m_oj_h@yahoo.com 01005034393 9said zulfakar st
City Postal code Country Position/Affiliation
Cairo 11555 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