| CTRI Number |
CTRI/2021/04/032963 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY COMPARISON OF
EFFICACY OF LEVETIRACETAM AND
MAGNESIUM SULPHATE IN THE MANAGEMENT OF ANTEPARTUM, INTRAPARTUM AND POSTPARTUM CONVULSIONS |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND
EFFICACY OF LEVETIRACETAM IN COMPARISON TO
MAGNESIUM SULPHATE IN THE MANAGEMENT OF ECLAMPSIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SR BIDRI |
| Designation |
PROFFESSOR |
| Affiliation |
Shri BM Patil Medical College |
| Address |
DEPARTMENT OF OBG BLDE DEEMED TO BE UNIVERSITY DR. BM PATIL ROAD VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9553223311 |
| Fax |
|
| Email |
srbidri6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SR BIDRI |
| Designation |
PROFFESSOR |
| Affiliation |
Shri BM Patil Medical College |
| Address |
DEPARTMENT OF OBG BLDE DEEMED TO BE UNIVERSITY DR. BM PATIL ROAD VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9553223311 |
| Fax |
|
| Email |
srbidri6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SR BIDRI |
| Designation |
PROFFESSOR |
| Affiliation |
Shri BM Patil Medical College |
| Address |
DEPARTMENT OF OBG BLDE DEEMED TO BE UNIVERSITY DR. BM PATIL ROAD VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9553223311 |
| Fax |
|
| Email |
srbidri6@gmail.com |
|
|
Source of Monetary or Material Support
|
| NOT APPLICABLE
SHRI BM PATIL MEDICAL COLLEGE BLDE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
Dr Sindhu Manne |
| Address |
DEPARTMENT OF OBG SHRI BM PATIL MEDICAL COLLEGE AND BLDE DEEMED TO BE UNIVERSITY DR. BM PATIL ROAD VIJAYAPURA
586103 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SINDHU MANNE |
Shri BM Patil Medical College and Research Center |
Department of OBG, OPD No. 2. Solapur Rd, Bangaramma Sajjan Campus
Bijapur
KARNATAKA |
9553223311
smanne521@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri BM Patil Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O159||Eclampsia, unspecified as to timeperiod, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LEVETIRACETAM |
1 G LOADING DOSE IV
500 MG BD MAINTENANCE DOSE IV IN 100 ML NS
RELATIVELY SAFE TO BE USED IN PREGNANCY |
| Comparator Agent |
MAGNESIUM SULPHATE |
PRITCHARDS REGIMEN. LOADING DOSE OF 4 G IV AND 10 G BOTH BUTTOCKS FOLLOWED BY MAINTENANCE DOSE OF 5 G ALTERNATE BUTTOCKS 4RTH HOURLY. ANTIEPILEPTIC RELATIVELY SAFE TO BE USED IN PREGNANCY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ALL PATIENTS PRESENTING WITH FEATURES OF ECLAMPSIA DURING THE SAID PERIOD WILL BE RECRUITED INTO THE STUDY
ALL PATIENTS GIVING INFORMED AND WRITTEN CONSENT FOR INVESTIGATIONS |
|
| ExclusionCriteria |
| Details |
PATIENTS WHO WERE DIAGNOSED WITH OTHER CAUSES OF CONVULSIONS IN PREGNANCY LIKE CEREBRAL MALARIA AND EPILEPSY
CHRONIC HYPERTENSIVE PREGNANT FEMALES
PREGNANT FEMALES WITH FETAL ANOMALIES DETECTED ON USG |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO OBSERVE FOR CONVULSIONS POST ANTIEPILEPTIC TREATMENT DURING THE PERIOD PATIENT IS IN HOSPITAL |
DURATION OF HOSPITAL STAY (1-2 WEEKS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2021 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
If the drug Levetiracetam can be proven to be as effective as magnesium sulphate and relatively safe in patients than further continued assessment and use of the drug can be done. |