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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201611037978N4 |
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Date of registration:
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2016-11-18 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Megafer injection® in Pregnant Women
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Scientific title:
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Efficacy and Safety Study of Injection Iron Sucrose in Pregnant Women with Iron Deficiency Anaemia |
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Date of first enrolment:
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2015-07-31 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/8412 |
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Study type:
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interventional |
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Study design:
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Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Single arm, Open label study.
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Phase:
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4
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Dr. Haleema Yasmeen
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Address:
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Rafiqui Shaheed Road, Jinnah Post Graduate Medical Centre
75510
karachi
Pakistan |
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Telephone:
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00922199201300 |
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Email:
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dr.haleemayasmin@yahoo.com |
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Affiliation:
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Department of Gynaecology, Jinnah Post Graduate Medical Centre |
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Name:
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Salman Rahim
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Address:
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510, 5th floor, commerce center, Hasrat Mohani Road
74200
Karachi
Pakistan |
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Telephone:
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0092213263631 |
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Email:
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salman.rahim@nabiqasim.com |
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Affiliation:
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Nabiqasim Industries (Pvt) Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria: Pregnant Women in second or third trimester, Hb: = 8 g/dl and serum ferritin levels are below than normal Exclusion Criteria: Patient allergic to iron preparation or any other ingredient of Injection megafer.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
40 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Iron Deficiency anemia, unspecified
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Iron Deficiency anemia.
Iron Deficiency anemia, unspecified
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Intervention(s)
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The total calculated dose was divided as 100 to 200 mg dose/day maximum once or twice in week. Firstly, 25mg (25ml) was infused over 30 minutes @12 drops /minute as a test dose and the remaining dose was given at the rate 30-36 drops /minute, aiming the target haemoglobin of 11g/dl.
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Treatment - Drugs
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The total calculated dose was divided as 100 to 200 mg dose/day maximum once or twice in week. Firstly, 25mg (25ml) was infused over 30 minutes @12 drops /minute as a test dose and the remaining dose was given at the rate 30-36 drops /minute, aiming the target haemoglobin of 11g/dl..
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Primary Outcome(s)
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Increase in Hb level after initiation of treatment, achievement of target haemoglobin. Timepoint: 2 & 4 weeks after first dose. Method of measurement: Haemoglobin testing.
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Secondary Outcome(s)
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Reported adverse events related to drug only. Timepoint: At every follow up visit. Method of measurement: Patient monitoring & Follow up calls to patients.
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Source(s) of Monetary Support
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Surge Laboratories Pvt. Ltd.
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Jinnah Post Graduate Medical Centre
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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