Pharmacokinetics profile of magnesium after intravenous and intramuscular magnesium sulfate administration in Indonesian pregnant women with pre-eclampsia

ISRCTN	ISRCTN13244564
DOI	https://doi.org/10.1186/ISRCTN13244564
Secondary identifying numbers	Randomized clinical trial

Submission date: 23/07/2015
Registration date: 31/08/2015
Last edited: 20/08/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Lily Marliany Surjadi
Public

Faculty of Medicine
Gadjah Mada University
jl. Farmako - Sekip
yogyakarta
55281
Indonesia

Prof Mustofa Jogja
Scientific

Bag. farmakologi
Fakultas Kedokteran Universitas Gadjah Mada
Yogyakarta
55281
Indonesia

Study information

Study design	Randomized clinical trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Pharmacokinetics profile of magnesium after intravenous and intramuscular magnesium sulfate administration in Indonesian pregnant women with pre-eclampsia: a randomized clinical trial
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	15/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	70
Key inclusion criteria	1. Single pregnancy 2. Pre-eclampsia 3. Willing to join the study
Key exclusion criteria	1. Magnesium intoxication 2. Other pregnancy complications
Date of first enrolment	01/06/2013
Date of final enrolment	15/07/2014

Locations

Countries of recruitment

Indonesia

Study participating centre

Subang District Hospital

West Java
Subang
41212
Indonesia

Sponsor information

Faculty of Medicine, Universitas Gadjah Mada
University/education

Jl. farmako - Sekip Utara
Yogyakarta
55281
Indonesia

Website	www.s3fk.ugm.ac.id
"ROR"	https://ror.org/03ke6d638

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Dissertation at Doctoral Program, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia Journal of Medical Science
IPD sharing plan