Condition category
Pregnancy and Childbirth
Date applied
23/07/2015
Date assigned
31/08/2015
Last edited
20/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

Trial website

Contact information

Type

Public

Primary contact

Dr Lily Marliany Surjadi

ORCID ID

Contact details

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

Type

Scientific

Additional contact

Prof Mustofa Jogja

ORCID ID

Contact details

Bag. farmakologi
Fakultas Kedokteran Universitas Gadjah Mada
Yogyakarta
55281
Indonesia

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Magnesium sulfate

Primary outcome measures

Serum magnesium level

Secondary outcome measures

Pharmacokinetics profile of magnesium sulfate

Overall trial start date

01/06/2012

Overall trial end date

15/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Single pregnancy
2. Pre-eclampsia
3. Willing to join the study

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

www.s3fk.ugm.ac.id

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes