FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2008/091/000119 [Registered on: 08/12/2008]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Standard dose and low dose of Magnesium sulphate in treatment of eclampsia 
Scientific Title of Study   Low dose magnesium sulphate regimen for management of eclampsia - a randomized controlled trial (An ICMR Tsak Force Study) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IRIS No 2006-0651 A to J dated 10/8/07  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Nomita Chandhiok, Dr Shalini Singh 
Designation   
Affiliation   
Address  Division of RHN, Indian Council of Medical Research,
Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  +91-11-26589493  
Fax  +91-11-26588755  
Email  n_chandhiok@hotmail.com,  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Singh 
Designation   
Affiliation  Scientist 'D' 
Address  Division of RHN, Indian Council of Medical Research,
Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  +91-11-26589493  
Fax  +91-11-26588755  
Email  shalinisingh_icmr@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shalini Singh 
Designation   
Affiliation   
Address  Division of RHN, Indian Council of Medical Research,
Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  +91-11-26589493  
Fax  +91-11-26588755  
Email  shalinisingh_icmr@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi - 110029 India 
 
Primary Sponsor  
Name  Central Co-ordinating Unit, Divivsion of RHN Indian Council of Medical Research Ansari Nagar New Delhi -110029  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr.K.P. Jhansi   Dept of Obs & Gyane  SAT Medical College ,-695011

 		 0471-2444270

sowminicv@gmail.com  
Dr L.K.Dhaliwal  Dept of Obs & Gynae  PGIMER,-160012
Chandigarh
CHANDIGARH 		 09417251020

lakhbir.d@rediffmail.com  
Dr Sheela Sharma  Dept of Obs & Gynae  Patna Medical College ,- 800001
Patna
BIHAR 		 0612-2264189

patnalowdose@sify.com  
Dr SL Pagi  Dept of Obs & Gynae  SSGS Medical College,-390001

 		 09824454998

hrrc_baroda@yahoo.com  
Dr. Joydev Mukherji  Dept of Obs & Gynae  RG Kar Medical College,1, Belgachia Main Road, -700004
Kolkata
WEST BENGAL 		 033-23558055

kol.lowdose@yahoo.co.in  
Dr. K.Saraswathi  Dept of Obs & Gynae  Instt of Obst & Gynae,No.11, Police Commissioner`s Office Road , Egmore-600008
Chennai
TAMIL NADU 		 09444489577

susi_saravanan@yahoo.co.in 
Dr.S.S. Revathy Janakiram   Dept of Obs & Gynae  Madurai Medical College,-625020
Madurai
TAMIL NADU 		 0452- 2340333

dr.revathyjanakiram@gmail.com  
Dr.Sudha Salhan  Dept of Obs & Gynae  Safdurjung Hospital,-110029
New Delhi
DELHI 		 011-26198108

sudha_salhan@yahoo.co.in  
Dr Vinita Das  Dept of Obst & Gynae  Chhatrapati Shahuji Maharaj Medical University,-226003
Lucknow
UTTAR PRADESH 		 9415023346

hrrc_lko@yahoo.co.in  
Dr BR Desai  Deptt. of Obst & Gynae  JLN Medical College,-590010
Belgaum
KARNATAKA 		 0831-2473777 (O)

bgm.lowdose@yahoo.co.in  
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
1. JNMC Institutional Ethics Committee on Human Subjects Research, JN Medical College, Belgaum  Approved 
2. Ethics Committee of Postgraduate Institute of Medical Education And Research, Chandigarh  Approved 
3. Ethical Committee, Patna Medical College, Patna  Approved 
4. Human Ethical Committee, Medical College, Thiruvananthapuram  Approved 
5. Ethics Committee, King George?s Medical College, Lucknow  Approved 
6. Ethical Committee of the Govt. Rajaji Hospital, Madurai  Approved 
7. Ethical committee of RG Kar Medical College & Hospital, Kolkata  Approved 
8. Ethical Committee, Institute of Obstetrics & Gynaecology, Egmore, Chennai  Approved 
9. Ethical Committee, Safdurjung Hospital, New Delhi  Approved 
Ethical Committee, SSG Medical College, Baroda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Magnesium sulphat - Pritchard regimen  Standard dose(Pritchard regimen): Loading dose = 14 gm [4gm I/V(20%) + 10gm I/M (50%)] Maintenance doses = 5gm I/M (50%) x 4 hrly Total dose in 24 hrs = 39gm  
Intervention  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  
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  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  
 
ExclusionCriteria 
Details  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)  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome : rate of recurrent convulsions in the two groups   Till discharge from hospital or death 
 
Secondary Outcome  
Outcome  TimePoints 
• 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 
 
Target Sample Size   Total Sample Size="1400"
Sample Size from India="" 
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 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/08/2007 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.  
Close