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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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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN13244564 |
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Date of registration:
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31/08/2015 |
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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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Pharmacokinetics profile of magnesium after intravenous and intramuscular magnesium sulfate administration in Indonesian pregnant women with pre-eclampsia
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Scientific title:
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Pharmacokinetics profile of magnesium after intravenous and intramuscular magnesium sulfate administration in Indonesian pregnant women with pre-eclampsia: a randomized clinical trial |
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Date of first enrolment:
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01/06/2013 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN13244564 |
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Study type:
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Interventional |
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Study design:
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Randomized clinical trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Lily Marliany
Surjadi |
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Address:
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Faculty of Medicine
Gadjah Mada University
jl. Farmako - Sekip
55281
yogyakarta
Indonesia |
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Telephone:
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Email:
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Affiliation:
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Name:
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Mustofa
Jogja |
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Address:
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Bag. farmakologi
Fakultas Kedokteran Universitas Gadjah Mada
55281
Yogyakarta
Indonesia |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Single pregnancy
2. Pre-eclampsia
3. Willing to join the study
Exclusion criteria: 1. Magnesium intoxication
2. Other pregnancy complications
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pre-eclampsia
Pregnancy and Childbirth
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Intervention(s)
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A total 70 pregnant women with pre-eclampsia were involved in this study. Subjects were divided into two groups with 35 subjects in each group. The intravenous group received an IV loading dose of MgSO4 solution, followed by a maintenance IV regimens of MgSO4. The intramuscular group received an IV loading dose MgSO4 solution, followed by a IM regimens of MgSO4. Serial blood samples were collected at 0; 10 min; 1; 2; 4; 24; 26; 28 and 30 h. The serum Mg concentrations were determined using the atomic absorption spectrophotometer method. Pharmacokinetics parameters including peak serum concentration (Cmax), time to reach peak concentration (Tmax), the area under the serum concentration versus time curve going to infinity (AUCo-8) and elimination half-life (t1/2), elimination rate constant (kel), clearance (Cl), and volume of distribution (Vd) were calculated using standard methods and compared between groups.
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Primary Outcome(s)
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Serum magnesium level
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Secondary Outcome(s)
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Pharmacokinetics profile of magnesium sulfate
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Secondary ID(s)
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Randomized clinical trial
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Source(s) of Monetary Support
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Investigator initiated and funded
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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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