Plain English Summary
Background and study aims
Pre-eclampsia is a potentially serious condition affecting pregnant women, usually during the second half of pregnancy or just after the baby is born. Symptoms include high blood pressure, protein in the urine, swelling of feet, ankles, face and hands, severe headache, vision problems and pain experienced below the ribs. If not treated, eclampsia may develop. Eclampsia is a type of fit, or seizure. This carries with it a small risk of permanent disability or brain damage if the fits are severe. Women with pre-eclampsia can prescribed magnesium sulphate. This drug can help prevent seizures in women with severe pre-eclampsia and decrease them in women with eclampsia. Drugs can been absorbed, distributed, metabolised and excreted (removed) by the body differently according to how it is given to the patient. This is called the drug pharmacokinetic profile. This study is looking at the pharmacokinetics profile of magnesium sulphate (MgSO4) given directly into the muscle (intramuscular) compared to the drug given into a vein (intravenous).
Who can participate?
Patients with preeclampsia from Subang District Hospital.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given an initial MgSO4 “loading dose” (higher starting dose) intravenously (IV) followed by a IV maintenance dose. Those in group 2 are given a IV plus intramuscular (IM) loading dose followed by a IM maintenance dose that is given every 4 hours. The therapy in both groups are stopped at 24 hours. Blood samples are collected at the start of the treatment and then after 10 minutes, 1 hour, 2 hours, 4 hours, 24 hours, 26 hours, 28 hours, and finally 30 hours after treatment begins. Serum magnesium level are determined in the laboratory. The pharmacokinetics profiles of magnesium for each group are obtained and compared.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Subang District Hospital (Indonesia)
When is the study starting and how long is it expected to run for?
June 2012 to July 2014
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Lily Marliany Surjadi (public)
2. Professor Mustofa Jogja (scientific)
Study website
Contact information
Type
Public
Contact name
Dr Lily Marliany Surjadi
ORCID ID
Contact details
Faculty of Medicine
Gadjah Mada University
jl. Farmako - Sekip
yogyakarta
55281
Indonesia
Type
Scientific
Contact name
Prof Mustofa Jogja
ORCID ID
Contact details
Bag. farmakologi
Fakultas Kedokteran Universitas Gadjah Mada
Yogyakarta
55281
Indonesia
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Randomized clinical trial
Study information
Scientific title
Pharmacokinetics profile of magnesium after intravenous and intramuscular magnesium sulfate administration in Indonesian pregnant women with pre-eclampsia: a randomized clinical trial
Acronym
Study hypothesis
IM (intramuscular) and IV (intravenous) administration of magnesium sulfate in pre-eclampsia show diffferent pharmacokinetics profile
Ethics approval(s)
The Medical and Health Research Ethics Committee (MHREC), Ministry of National Education, Faculty of Medicine Gadjah Mada University, ref: KE/FK/556/EC
Study design
Randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Pre-eclampsia
Intervention
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-∞) 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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Magnesium sulfate
Primary outcome measure
Serum magnesium level
Secondary outcome measures
Pharmacokinetics profile of magnesium sulfate
Overall study start date
01/06/2012
Overall study end date
15/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Single pregnancy
2. Pre-eclampsia
3. Willing to join the study
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
70
Participant exclusion criteria
1. Magnesium intoxication
2. Other pregnancy complications
Recruitment start date
01/06/2013
Recruitment end date
15/07/2014
Locations
Countries of recruitment
Indonesia
Study participating centre
Subang District Hospital
West Java
Subang
41212
Indonesia
Sponsor information
Organisation
Faculty of Medicine, Universitas Gadjah Mada
Sponsor details
Jl. farmako - Sekip Utara
Yogyakarta
55281
Indonesia
Sponsor type
University/education
Website
ROR
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Dissertation at Doctoral Program, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia
Journal of Medical Science
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|