A clinical trial to study the effect of Standard dose and low dose of Magnesium sulphate in treatment of eclampsia

Phase 3

• Conditions: Eclampsia

• 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

This is a multicentric, open label, randomized controlled trial to compare the effect of a lower dose regimen of magnesium sulphate (20.5 gm) as compared to the standard regimen (39 gm) in the management of eclampsia patients. Ten participating sites will enroll a total of 1400 women with Cardiac Biochemistry Laboratory at All India Institute of Medical Sciences, New Delhi as the central Laboratory and ICMR as the central co-ordinating unit. The primary outcome will be recurrent convulsions and secondary outcomes will be maternal & fetal outcome, signs of toxicity in the mother and newborn, use of additional medications for control of convulsions and adverse drug reactions. Serum magnesium will be estimated in 25% of subjects enrolled (randomly selected) and their newborns.

Detailed Description

Not available

Recruitment & Eligibility

• 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 delivery3.uncertainty of diagnosis4.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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome : rate of recurrent convulsions in the two groups	Till discharge from hospital or death

Secondary Outcome Measures

Name	Time	Method
•Signs of Magnesium toxicity in the mother (flushing, nausea, double vision, diminished or absent deep tendon reflexes, respiratory rate less than 16/mt)•Signs of Magnesium toxicity in the newborn(respiratory depression, hypotonia, hypotension)•Adverse drug reaction(respiratory paralysis, cardiac arrest, need for administration of calcium gluconate) •Additional medication for control of convulsions•Complications of labor and delivery e.g prolonged labor, postpartum hemorrhage, retained placenta •Maternal and fetal outcomes •Number of days of hospital stay including stay in Medical ICU/Neonatal ICU	til discharge from hospital or death

Trial Locations

Locations (4)

Dept of Obs & Gyane; 🇮🇳 College, India

Dept of Obs & Gynae; 🇮🇳 Delhi, DELHI, India

Dept of Obst & Gynae; 🇮🇳 Lucknow, UTTAR PRADESH, India

Deptt. of Obst & Gynae; 🇮🇳 Belgaum, KARNATAKA, India

Dept of Obs & Gyane

🇮🇳College, India

Dr.K.P. Jhansi

Principal investigator

sowminicv@gmail.com