Comparing two regimens of magnesium sulphate for treatment of eclampsia in pregnant women

Phase 4

Recruiting

Conditions: Eclampsia during pregnancy and postpartum period

Registration Number: CTRI/2012/04/002594

Brief Summary: This study is a randomised, parallel group, open lebel trial compairing the efficacy of two regimens of low dose magnesium sulphate for the treatment of eclapsia in Indian women. In this trial, two regimens of (low dose) magnesium sulphate in the treatment of eclampsia are compared.

(1) In Control Group: low dose magnesium sulphate (loading plus maintenance dose) is used to control convulsions.

(2) In STUDY Group: Only loading dose of magnesium sulphate will be used (no maintenance dose) for control of convulsions.

The outcomes of study and control groups are compared in terms of:

(a) Rate of recurrent convulsions in mothers.

(b) Maternal mortality and morbidity

(c) Total amount of magnesium sulphate received by each woman.

(d) Clinical evidence of magnesium toxicity.

(e) Perinatal mortality and morbidity

This study will explore how efficiently magnesium sulphate can be used for eclampsia without producing maternal toxicity, and avoiding undue prolonged treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 150

Inclusion Criteria

All cases of eclampsia â€“ antepartum, intrapartum, postpartum with following diagnostic criteria: a)Hypertension where BP 140/90 mm Hg or more b)Proteinuria (more than 0.3g/L or more than + 1) c)Convulsion occurring at gestational age > 20 weeks, or within 48 h of delivery.

Exclusion Criteria

Eclampsia with the following conditions will be excluded: a.Renal failure b.Deeply comatosed c.Hypotensive patient d.Clinical or imaging evidence suggestive of intracranial haemorrhage e.Diagnosis is doubtful f.Patients who had other causes of convulsions such as epilepsy, meningitis, trauma, and cerebral malaria etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcomes of two regimens are compared in terms of	Till discharge
a)Rate of recurrent convulsions	Till discharge
b)Maternal mortality	Till discharge

Secondary Outcome Measures

Name	Time	Method
1. Magnesium Sulphate â€“ a)Total amount of magnesium sulphate received by each patient with or without maintenance dose	b) Total no. of maintenance dose received

Trial Locations

Locations (1): Department of Obstetrics and Gynaecology, Burdwan Medical College & Hospital, Burdwan
🇮🇳
Barddhaman, WEST BENGAL, India
Department of Obstetrics and Gynaecology, Burdwan Medical College & Hospital, Burdwan
🇮🇳Barddhaman, WEST BENGAL, India
Professor Narayan Jana
Principal investigator
09331035392
drnjana@gmail.com