Prevention of eclampsia in patients with pre-eclampsia Pregnancy and Childbirth
Conditions
Interventions
Experimental arm
Women in the intervention arm will receive the simplified regimen of two IM doses of 10g magnesium sulphate 12 hours apart.
Active control arm
Women in the active control arm will r
each pack will contain the required number of magnesium sulfate ampoules for the simplified or standard regimen according to the randomization sequence. The packs will be assembled consecutively in sp
Sponsors
World Health Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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 =160 mmHg, or diastolic blood pressure =110 mmHg 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.
Exclusion criteria
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal eclamptic seizure: occurrence of first onset of convulsions in a woman with features of pre-eclampsia that is unrelated to other neurological conditions; as documented on a participants trial chart or medical records from the time of randomization until day 7 after birth, hospital discharge, transfer to higher-level/another facility, withdrawal from study, or maternal death; whichever is first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 toxicity: the occurrence of any of the above events related to maternal toxicity, individually documented on the participant’s STEPMag chart- which documents hourly assessments for these events. 1.1 Patella reflexes as assessed by the obstetric care provider during magnesium sulfate treatment; as documented on a scale from 0 to +4; where 0 is absent reflexes, +2 is normal, and + 4 is a sustained response. Tendon reflexes are assessed from randomization until 24 hours after start of treatment and recorded in the participant STEP-Mag chart. 1.2 Respiratory depression, defined as a respiratory rate of less than 16 respirations/minute as assessed by the obstetric care provider during magnesium sulfate treatment and recorded in the participant STEP-Mag chart. 1.3 Use of calcium gluconate, defined as the use of calcium gluconate given at any time during treatment to combat perceived or confirmed magnesium sulfate toxicity and recorded in the participant STEP-Mag chart. 1.4 Stopping/reduced magnesium sulfate treatment due to perceived/confirmed magnesium toxicity; as documented in the participant STEPMag chart as the rationale for the obstetric provider to lower (e.g., halving) the dose of magnesium sulfate treatment regimen, as defined in the protocol. 2. Maternal death (all-cause and cause-specific): the death of a woman and the underlying cause, measured using a review of patient notes for events up to day 7 after birth, hospital discharge, transfer to higher level of care, maternal death, or withdrawal from the study; whichever is first. 3. Death of baby before hospital discharge (stillbirth, perinatal death or neonatal death, | — |
Countries
Egypt, India, Kenya, Malawi, Nigeria, Rwanda, South Africa, Uganda
Outcome results
None listed