A clinical trial to study the effect of Standard dose and low dose of Magnesium sulphate in treatment of eclampsia
Phase 3
- Registration Number
- CTRI/2008/091/000119
- Lead Sponsor
- Central Co-ordinating Unit,Divivsion of RHNIndian Council of Medical Research Ansari NagarNew Delhi -110029
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1400
Inclusion Criteria
1.All consecutive eligible women admitted with a provisional diagnosis of eclampsia
2.Willing to participate in the trial and provide a written informed consent
Exclusion Criteria
1.Diagnosed cases of (a) pre-existing seizure disorder
(b) myasthenia gravis
(c) heart block
(d) Addison disease
2.cases of post partum eclampsia with of onset of convulsions 72 hours after delivery
3.uncertainty of diagnosis
4.signs of magnesium toxicity in patients who have received MgSO4 therapy in the periphery( diminished or absent deep tendon reflexes and/or respiratory rate <16/mt)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome : rate of recurrent convulsions in the two groupsTimepoint: Till discharge from hospital or death
- Secondary Outcome Measures
Name Time Method â?¢Signs of Magnesium toxicity in the mother (flushing, nausea, double vision, diminished or absent deep tendon reflexes, respiratory rate less than 16/mt)<br>â?¢Signs of Magnesium toxicity in the newborn(respiratory depression, hypotonia, hypotension)<br>â?¢Adverse drug reaction(respiratory paralysis, cardiac arrest, need for administration of calcium gluconate) <br>â?¢Additional medication for control of convulsions<br>â?¢Complications of labor and delivery e.g prolonged labor, postpartum hemorrhage, retained placenta <br>â?¢Maternal and fetal outcomes <br>â?¢Number of days of hospital stay including stay in Medical ICU/Neonatal ICU<br>Timepoint: til discharge from hospital or death