Health Condition 1: O159- Eclampsia, unspecified as to timeperiod
Conditions
Interventions
Intervention1: simplified regimen of Magnesium sulphate: Women in the intervention arm will receive the simplified regimen of two IM doses of 10g magnesium sulphate 12 hours apart
Control Intervention
Sponsors
World Health Organization
Eligibility
Inclusion criteria
Inclusion criteria: Women meeting all of the following criteria: 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 more than or equal to 160 mm Hg, or diastolic blood pressure more than or equal to 110 mm Hg along with more than or equal to 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 (less than 100 cells per 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
Exclusion criteria
Exclusion criteria: Women are not eligible if they fulfill any of the following exclusion criteria: 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. Less than 18 years of age. 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 (less than 400mL urine in 24 hours) at the time of admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal eclamptic seizure (defined as occurrence of convulsions in a woman with features of pre-eclampsia that is unrelated to other neurological conditions)Timepoint: until the time of hospital discharge or transfer to a higher care unit or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcome 1. Composite endpoint describing events related to maternal toxicity and consisting of one or more of the following: absent/reduced tendon reflexes, respiratory depression, use of calcium gluconate to counteract perceived/confirmed maternal toxicity, or stopping/reduced magnesium sulfate treatment in the event of perceived/confirmed maternal toxicityTimepoint: until the time of hospital discharge or transfer to a higher care unit or death;Other secondary outcomes 2. Maternal death (all-cause and cause-specific) 3. Death of baby before hospital discharge (stillbirth, perinatal death or neonatal death, for women enrolled before giving birth)Timepoint: until the time of hospital discharge or transfer to a higher care unit or death;4. Indicators of severe maternal morbidity (respiratory arrest, cardiac arrest, coagulopathy, renal failure, liver failure, pulmonary oedema, and stroke) 5. Maternal intensive care unit (ICU) admission 6. Recurrence of seizures (for women with eclampsia)Timepoint: until the time of hospital discharge or transfer to a higher care unit or death;7. Maternal side effects of magnesium sulfate (nausea or vomiting, flushing of the skin, drowsiness, confusion, muscle weakness, problem at injection site â?? pain, injection abscess with IM or IV administration)Timepoint: until the time of hospital discharge or transfer to a higher care unit or death;8. Mode of birth (caesarean section or vaginal birth) 9. Induction of labour 10. Augmentation of labour 11. Abruptio placenta 12. Postpartum haemorrhage (estimated blood loss â?¥ 500 mL with vaginal birth or â?¥ 1000 mL with caesarean birth, treatment with additional uterotonics for haemorrhage, blood transfusion) 13. Retained placentaTimepoint: until the time of hospital discharge or transfer to a higher care unit or death;14. Indicators of severe neonatal morbidity (Apgar less than 7 at 5 minutes, need for intubation at birth, ventilation, seizures, admission to neonatal | — |
Countries
Egypt, India, Kenya, Malawi, Nigeria, Rwanda, South Africa, Uganda
Contacts
Public ContactDr Shivaprasad S Goudar
KLE Academy of Higher Education and Researchs J N Medical College
Outcome results
None listed