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

Low dose magnesium sulphate regimen for management of eclampsia - a randomized controlled trial (An ICMR Tsak Force Study)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000119

Enrollment

1400

Registered

2008-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Magnesium sulphate- low dose: Low Dose regimen: Loading dose = 8gm [3gm I/V (20%)+ 5gm I/M (50%)] Maintenance doses = 2.5 gm I/M (50%) x 4 hrly Total dose in 24 hrs = 20.5gm Control I

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Primary outcome : rate of recurrent convulsions in the two groupsTimepoint: Till discharge from hospital or death	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Shalini Singh

Scientist 'D'

shalinisingh_icmr@yahoo.co.in+91-11-26589493

Outcome results