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.: PACTR201707002409642 Date of Approval: 06/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Corticosteroids for RH isoimmunization
Official scientific title ORAL PREDNISOLONE VERSUS INTRAUTERINE TRANSFUSION IN ISOIMMUNIZED PREGNANT FEMALES WITH RH INCOMBATIBILITY
Brief summary describing the background and objectives of the trial Rh negative women become isoimmunized anti Rh-D antigen if they donot receive Anti-D antibodies after delivery or miscarriage. This problem leads to fetal hemolysis and immune hydrops fetalis. Established treatment is by repeated intrauterine cordocentesis and packed RBC transfusion to the fetus. This procedure carries the risk of infection, premature rupture of membranes and preterm labour. Corticosteroids have been successfully used for the treatment of autoimmune disorders. Our study aims to use Prednisolone for this Allo-immune disorder. The use of corticosteroids is safe in pregnancy. Only cleft lip or palate haas been reported in animal trial. Our study will be a randomized prospective trial with two arms: 10 patients will receive 40 mg of prednisolone will be used in isoimmunized cases after 10 weeks of gestation. Follow-up of anti-Rh antibodies titre and peak systolic velocity in middle cerebral artery of the fetus for early detection of fetal anemia. The other group of 10 pateints will receive the established treatment of repeated packed RBC transfusion, with the same follow-up. Delivery will be planned at 34 weeks gestation 24 hours after administration of 4 doses of intramuscular dexamethasone 12 hours apart.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Rh isoimmunization, immune hydrops fetalis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 06/07/2017
Actual trial start date 06/07/2017
Anticipated date of last follow up 30/07/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status 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 computer generated numbers.SPSS version 20 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group predisolone tablets 20 mg tablets twicw a day 10th-34th week of gestation oral medication 10 Active-Treatment of Control Group
Control Group O negative RBCs patients receiving packed O negative RBCs 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant females Rh negative blood group Indirect Coomb's test positive of Anti-Rh antibodies titre above 1/16 Cases with established hydrops fetalis 18 Year(s) 45 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 06/03/2017 Faculty of medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevention of fetal anemia Every two weeks by checking of peak systolic velocity in middle cerebral artery
Primary Outcome Lowering of anti-Rh antibodies titre Every two weeks from week 10 of gestation
Primary Outcome Prevention of fetal anemia and hydrops fetalis At 34 weeks of gestation
Secondary Outcome Delivery of a healthy fetus gestation At 34 weeks of gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shatby Maternity university hospital Army road, next to library of Alexandria Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine Raml station Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Raml station Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tamer Mamdouh abdel Dayem 8 faculty of medicine street Alexandria 21526 Egypt
Tarek Abdel Zaher karkor Commerial room street Alexandria 21526 Egypt
Louay Hassan Zayed Roman Camp street Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Abdel Dayem tmdaeim@gmail.com 0020126720766 8 faculty of medicine street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Associate professor
Role Name Email Phone Street address
Public Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 0020126720766 8 faculty of medicine street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Associate professor
Role Name Email Phone Street address
Scientific Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 0020126720766 8 faculty of medicine street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Associate professor
REPORTING
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Result URL Hyperlinks
Changes to trial information