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CTRI Number  CTRI/2016/07/007076 [Registered on: 12/07/2016] Trial Registered Retrospectively
Last Modified On: 09/07/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Safety and Efficacy of abbreviated (12 hr) Magnesium Sulfate (MgSO4) therapy) vs. traditional 24 hrs therapy after delivery in Severe Preeclampsia: A Randomized Clinical Trial 
Scientific Title of Study   : Safety and Efficacy of abbreviated (12 hr) Magnesium Sulfate (MgSO4) therapy) vs. traditional 24 hrs therapy after delivery in Severe Preeclampsia: a Randomized Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradip Kumar Saha 
Designation  Assistant Professor 
Affiliation  PGIMER, Chandigarh 
Address  Deptt of Obstetrics and Gynaecology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
910172
India 
Phone    
Fax    
Email  pradiplekha@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradip Kumar Saha 
Designation  Assistant Professor 
Affiliation  PGIMER, Chandigarh 
Address  Deptt of Obstetrics and Gynaecology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
910172
India 
Phone    
Fax    
Email  pradiplekha@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Pradip Kumar Saha 
Designation  Assistant Professor 
Affiliation  PGIMER, Chandigarh 
Address  Deptt of Obstetrics and Gynaecology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
910172
India 
Phone    
Fax    
Email  pradiplekha@yahoo.co.in  
 
Source of Monetary or Material Support  
Intramural research project PGIMER chandigarh 
 
Primary Sponsor  
Name  DirectorPGIMER Chandigarh 
Address  Director,PGIMER, Chandigarh 160012 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr PRADIP K SAHA  PGIMER,Chnadigarh  PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH 		 919914209341

pradiplekha@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intramural Ethics Review Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant women with severe preeclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  12 hours of magnesium sulfate  Patients in this group will have magnesium sulfate administered for 12 hours after delivery.Mgso4 to be given 14 gm loading dose(5gm in each buttock IM and 4 gm IV) followed by 5 gr every 4hourly till 12 hours of delivery 
Comparator Agent  24 hours of magnesium sulfate   Patients in this group will have magnesium sulfate administered for 24 hours after delivery.Mgso4 to be given 14 gm loading dose(5gm in each buttock IM and 4 gm IV) followed by 5 gr every 4hourly till 24 hours of delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Inclusion Criteria

1. Women with severe-preeclampsia, diagnosed during ante partum, intrapartum, or postpartum, are eligible for inclusion after delivery.
A diagnostic criterion for severe preeclampsia includes:
• sustained systolic blood pressure of ≥160 mm Hg;
• sustained diastolic blood pressure of ≥110 mm Hg;
• proteinuria >3 + on dipstick or ≥5 g/24- hour urine collection;
• oliguria (urine output <500 mL in 24 hours );
• the presence of persistent headache, visual disturbances, or epigastric or right upper quadrant pain; thrombocytopenia ; impaired liver function; pulmonary edema or cyanosis;
• fetal growth retardation;
• or superimposed severe pre-eclampsia with pre-existing chronic hypertension.

2. Agree to comply with study procedures;
3. > 18 years of age;
4. Give informed consent for study participation
 
 
ExclusionCriteria 
Details  Exclusion Criteria

• Associated maternal diseases;
• Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
• Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
• Comatosed patients
• Pulmonary oedema
• Oliguria
• Patients who have received MgSO4, Phenytoin, Diazepam before coming to hospital
• Intra cranial bleeding
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Maternal: Recurrence of fits, signs of magnesium toxicity like loss of knee jerk, respiratory depression, and any other maternal complications like coagulation failure, oliguria, renal failure, and pulmonary oedema will be recorded. Details of labour and delivery will be recorded.  Outcome will be assed till48 hours of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
2. Serum Magnesium level in maternal blood  at 5 mins, 4 hrs, 12 hrs and 24 hrs 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   05/10/2013 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   MgSO4 is the ideal drug for seizure prophylaxis in preeclampsia but the ideal duration of this treatment after delivery is still to be established. different schemes have been offered to shorten the exposure to MgSO4 after delivery, with little data. the hypothesis is that in stable patients a short course of treatment is possible without prejudice to the mother. however, there is no consensus on the appropriate duration of prophylactic use of MgSO4 in severe preeclampsia. there fore, the present study has been planed to campare  the 12 hrs vs 24 hrs MgSO4 therapy after delivery. 
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