| CTRI Number |
CTRI/2012/04/002594 [Registered on: 24/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
13/06/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Comparing two regimens of magnesium sulphate for treatment of eclampsia in pregnant women |
|
Scientific Title of Study
|
COMPARISION OF TWO REGIMENS OF LOW DOSE MAGNESIUM SULPHATE FOR TREATMENT OF ECLAMPSIA: LOADING PLUS 24-HOUR MAINTENANCE DOSE VERSUS LOADING DOSE ONLY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saswati Maiti |
| Designation |
Resident Trainee |
| Affiliation |
Burdwan Medical College |
| Address |
Department of Obstetrics and Gynaecology,
Burdwan Medical College,
Burdwan 713104
same
Barddhaman
WEST BENGAL
713104
India |
| Phone |
|
| Fax |
|
| Email |
maiti.saswati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Narayan Jana |
| Designation |
Professor & Head |
| Affiliation |
Burdwan Medical College |
| Address |
Professor Narayan Jana,
Professor and Head,
Department of Obstetrics and Gynaecology,
Burdwan Medical College,
Burdwan 713104
same
Barddhaman
WEST BENGAL
713104
India |
| Phone |
|
| Fax |
|
| Email |
drnjana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Narayan Jana |
| Designation |
Professor & Head |
| Affiliation |
Burdwan Medical College |
| Address |
Professor Narayan Jana,
Professor and Head,
Department of Obstetrics and Gynaecology,
Burdwan Medical College,
Burdwan 713104
same
Barddhaman
WEST BENGAL
713104
India |
| Phone |
|
| Fax |
|
| Email |
drnjana@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT. OF OBSTETRICS AND GYNAECOLOGY , BURDWAN MEDICAL COLLEGE & HOSPITAL, BURDWAN |
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Professor Narayan Jana |
Department of Obstetrics and Gynaecology, Burdwan Medical College & Hospital, Burdwan |
Department of Obstetrics and Gynaecology, Burdwan Medical College and Hospital, Burdwan 713104 , West Bengal, India.
Barddhaman
WEST BENGAL |
09331035392
342-2658646
drnjana@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Burdwan Medical College, Burdwan, West Bengal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Eclampsia during pregnancy and postpartum period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MAGNESIUM SULPHATE - control group |
CONTROL GROUP
Loading dose:
Magnesium sulphate (3g) slow IV injection over a period of not less than 5 minute, preferably 10 minute. Magnesium sulphate (50%) 6ml diluted with 14ml of 5% dextrose. Magnesium sulphate (2.5g) deep IM in each buttock (5ml 50%)
Maintenance dose:
Magnesium sulphate (2.5g) deep IM in the alternate buttocks every 4 hours.
STUDY GROUP
Loading dose:-
Magnesium sulphate (3 g) slow IV injection over a period of not less than 5 minute, preferably 10 minute. Magnesium sulphate (50%) 6ml diluted with 14ml of 5% dextrose. Magnesium sulphate (2.5g) deep IM in each buttock (5ml 50%).
Maintenance dose:
Nil.
Additional dose: Recurrent convulsion- magnesium sulphate 1g IV slowly in 5 minute magnesium sulphate (50%) 2ml diluted with 8ml 5% dextrose.
In the study group, same protocol will be followed except there is no maintenance dose. If there is recurrence of convulsion, additional dose of 1g IV will be given as noted in study group. But if the patient have more than 1 recurrent convulsions patient will be given maintenance dose as per protocol followed in control group.
|
| Intervention |
MAGNESIUM SULPHATE - STUDY GROUP |
Loading dose:
Magnesium sulphate (3 g) slow IV injection over a period of not less than 5 minute, preferably 10 minute. Magnesium sulphate (50%) 6ml diluted with 14ml of 5% dextrose. Magnesium sulphate (2.5g) deep IM in each buttock (5ml 50%).
Maintenance dose:
Nil
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All cases of eclampsia – 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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcomes of two regimens are compared in terms of
a) Rate of recurrent convulsions
b) Maternal mortality |
Till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Magnesium Sulphate – a)Total amount of magnesium sulphate received by each patient with or without maintenance dose
b) Total no. of maintenance dose received
c) Total no. of additional dose of magnesium sulphate received
d) clinical evidence of magnesium toxicity such as absent patellar jerk, respiratory depression to be found
2. Mode of delivery
Normal delivery/ caesarean section/ forceps
3. Maternal morbidity
4. Perinatal mortality
5.Neonatal morbidity |
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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.
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