Journal article

Publication year: 2003

Pages: 168-175

Journal: European Journal of Obstetrics & Gynecology and Reproductive Biology

Volume number: 107

Issue number: 2

ISSN: 0301-2115

eISSN: 1872-7654

DOI Link: https://doi.org/10.1016/S0301-2115(02)00368-8

Publisher: Elsevier

Abstract: 
An open-label, randomised, parallel-group, study was conducted in three study centres in women with premature labor and indication for a single agent intravenous tocolysis therapy with magnesium sulphate. The aim of this study was to examine the local and general tolerability and side-effects of magnesium sulphate for tocolysis. Furthermore, we tested the tolerability of a ready-for-use magnesium solution. No measurements of efficacy were performed during this study. Initially, patients received a loading dose of 4.0 g magnesium sulphate administered over 30 min. Thereafter, a continuous intravenous infusion of 1-2 g magnesium sulphate per hour up to 21 days was given. Venous score (Maddox), vital signs, adverse events as well as general tolerability (assessed by investigator and patients) and blood parameters were assessed. We showed good local and systemic tolerability of high dose magnesium sulphate for tocolysis. Only seven patients (15%) were withdrawn from the study prematurely due to minor adverse events. Potential serious complications of MgSO4 such as respiratory arrest or clinically relevant respiratory depression were not observed. The most frequently reported local adverse events were injection site pain, itching, erythema, swelling, induration and palpable venous cord. The most common systemic adverse events considered to be possibly related to the study drugs involved the nervous system (dizziness) followed by the digestive system (nausea, constipation). Systolic and diastolic blood pressure changed only slightly during the treatment. Respiratory rate and body temperature remained stable also. Toxic magnesium levels (>2.5 mmol/l) were not observed. The assessment of the clinical investigators with regard to tolerability was very good or good in 72.5% of the patients. The introduction of the ready-to-use solution has the advantage of eliminating the need to mix the solution prior to administration. This means a lower risk of overdose and contamination. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.

Harvard Citation style: Zygmunt, M., Heilmann, L., Berg, C., Wallwiener, D., Grischke, E., Münstedt, K., et al. (2003) Local and systemic tolerability of magnesium sulphate for tocolysis, European journal of obstetrics & gynecology and reproductive biology, 107(2), Article PII S0301-2115(02)00368-8. pp. 168-175. https://doi.org/10.1016/S0301-2115(02)00368-8

APA Citation style: Zygmunt, M., Heilmann, L., Berg, C., Wallwiener, D., Grischke, E., Münstedt, K., Spindler, A., & Lang, U. (2003). Local and systemic tolerability of magnesium sulphate for tocolysis. European journal of obstetrics & gynecology and reproductive biology. 107(2), Article PII S0301-2115(02)00368-8, 168-175. https://doi.org/10.1016/S0301-2115(02)00368-8