Simplified treatment for eclampsia prevention using magnesium sulfate: a phase III, randomised, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis

World Health Organization0 个研究点目标入组 12,000 人开始时间: 2022年7月29日最近更新: 2024年1月15日

试验速览

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•1. Be admitted with a diagnosis of pre-eclampsia and with clinical or laboratory indication(s) for magnesium sulfate treatment, as defined by any of the following: two readings of systolic blood pressure =160 mm Hg, or diastolic blood pressure =110 mm Hg along with =2+ proteinuria on urine dipstick; or the presence of symptoms, signs or laboratory findings suggestive of severe disease such as headache, visual disturbances, upper abdominal pain, pulmonary oedema, nausea and vomiting, hyperreflexia or clonus, elevated liver enzymes, raised serum creatinine, or thrombocytopenia. Women with HELLP syndrome, a severe form of pre-eclampsia characterized by Haemolysis, Elevated Liver enzymes, and Low Platelets (<100 cells/mcl) will be included if there is no clinical contraindication to IM injection.
•2. Have not yet given birth but birth is planned or expected within the next 24 hours, or have given birth within the last 24 hours.
•3. Provide written informed consent before any trial-related procedures are carried out.

•1. Unable or unwilling to give informed consent (because the woman is too distressed or not capable to understand, confirm and give informed consent due to emergency or health condition, or does not wish to be randomized for whatever reason).
•2. Are non-emancipated minors (as per local regulations) without a guardian.
•3. History of hypersensitivity to magnesium sulfate.
•4. Serious cardiovascular disorders (WHO classification III or IV or acute heart failure).
•5. Serious hepatic (encephalopathy or coma) or renal disease.
•6. History of epilepsy.
•7. Myasthenia gravis or any muscular dystrophies.
•8. Coagulopathy.
•9. Have previously received magnesium sulfate for eclampsia prevention in the current pregnancy.
•10. Planned to receive magnesium sulfate regimen other than the regimens specified for the trial on account of other medical indication(s) (e.g. fetal neuroprotection).
•11. Known oliguria (<400mL urine in 24 hours) at the time of admission.

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