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Donel Suhaimi1, Ratu Astuti Dwi Putri1, Yulis Hamidy2, Maya Savira3

1Department of Obstetrics and Gynaecology, Faculty of Medicine, Universitas Riau, Pekanbaru 28293, Indonesia
2Department of Pharmacology, Faculty of Medicine, Universitas Riau, Pekanbaru 28293, Indonesia

3Department of Microbiology, Faculty of Medicine, Universitas Riau, Pekanbaru 28293, Indonesia


Corresponding author:
Donel Suhaimi, MD, PhD
Associate Professor
Department of Obstetrics and Gynaecology, Faculty of Medicine, Universitas Riau, Pekanbaru, 28293, Indonesia

Email: donelmy@yahoo.com


TitlePostpartum Severe Preeclampsia Maternal Outcomes In 12-Hours Versus 24-Hours Maintenance Doses of Magnesium Sulfate Administration: Randomized Control Trial
MethodologyRandomized, controlled trial, double-blind study, prospective approach
Study durationThe estimated duration for the main protocol (e.g. from the start of screening to the last subject processed and finishing the study) is approximately 1 year
Study CentersMulticenter, four hospitals in Riau Province of Indonesia:
1.      Arifin Achmad Hospital
2.      Tengku Rafian Siak Sri Indrapura Hospital
3.      Dumai Hospital
4.      Bengkalis Hospital
5.      Selasih Hospital
ObjectivesPrimary Objective:
to analyze the effectiveness and evaluate the duration of postpartum maintenance dose magnesium sulfate administration in severe preeclampsia given within 12 hours compared to 24 hours.
Number of Subjects80 randomized patients
Diagnosis and Main Inclusion CriteriaPregnant women with severe preeclampsia at study centers. Participants who meet the research inclusion criteria and are not included in the exclusion criteria, and have agreed to participate in the study.
The inclusion criteria were:
a)       All pregnant women diagnosed with severe preeclampsia were treated by the research team
b)       Pregnant women with severe preeclampsia who are eligible for magnesium sulfate administration and get a loading dose of magnesium sulfate Zuspan.
c)        Postpartum severe preeclampsia mothers who received a maintenance dose of magnesium sulfate Zuspan.
All severe preeclampsia patients with decreased consciousness; had complications such as eclampsia, HELLP syndrome, kidney failure, or acute pulmonary oedema; in labour; received antihypertensive therapy in the last 12 hours; had an allergy to the trial drugs; and had asthma and heart disease were excluded.
The drop-out criteria were: the mother during the duration of the study, the mother showed allergy symptoms that were not previously known.
Study Product, Dose, Route, RegimenAll severe preeclampsia patients who came to the hospitals were subjected to anamnesis, physical and laboratories examination, and then selected based on predetermined inclusion criteria. If the patients met the requirements, they were asked to participate in the study and all patients have to sign the written informed consent before the enrolment.
Participants have carried out anamnesis, physical examination, diagnostic support, and initial management, namely in the form of hemodynamic stabilization, administration of antihypertensive drugs, and administration of magnesium sulfate (Zuspan method), namely the administration of an initial dose of 4 grams intravenously given bolus within 15 minutes, followed by intravenous maintenance dose of 1-2 grams per hour in 83.33 cc of crystalloid fluid. The assigned group was computerized and randomized using Randomizer software.
A total of 80 kits have been provided containing the trial drug. In an effort to optimize double blinding, each drug kit is filled with 4 bottles of 500 cc crystalloid liquid infusion and 4 syringes filled with medicine. For example, in drug kit 1 is 12-hour magnesium sulfate, then the kit contains 4 drug syringes that have been given a sequence number according to administration in the form of 2 syringes containing 40% magnesium sulfate 6 grams, 2 placebo syringes and 4 bottles of 500 cc crystalloid liquid infusion. Health workers are instructed to administer the drug by inserting the drug in a syringe containing the drug (volume 15 cc) that has been given the sequence number (numbers 1, 2, 3, and 4) into the crystalloid infusion fluid (syringe number 1 is inserted into 500 cc of crystalloid fluid) spent within 6 hours, and so on for up to 24 hours. Serum magnesium levels were assessed at 18 hours and 30 hours after postpartum magnesium sulfate administration in each group of study samples taken from peripheral veins and assessed using a blood serum measuring instrument at a laboratory designated as a research laboratory. Research can be stopped at any time without waiting for the number of respondents to be reached if the research shows poor results.
Health workers then record patient data based on predetermined coding kits, monitoring maternal outcomes, fetal outcomes, serum magnesium levels, laboratory values before and after MgSO4 administration, and side effects that occur using measuring instruments that have been included in the operational definition. All activities are documented in the patient's medical record. The data obtained is then recorded, compiled, and analyzed statistically.
Statistical MethodologyStatistical analysis is performed using computerized statistical analysis software. Univariate analyses (numerical, categorical data) are described as characteristics of the research subject and presented in tabulated form and then described. The data will be tested for normality and validity of the independent t-test. The results of statistical tests in this study are considered meaningful if a p-value of <0.05 is obtained.
The endpoints of this study were: (a) Maternal primary outcomes (incidence of eclampsia and maternal mortality, duration of a urinary catheter, duration of hospital stay, mobilization start time, cost of treatment, serum magnesium levels) and (b) Maternal secondary outcomes i.e. side effects and clinical symptoms of magnesium sulfate toxicity.