| CTRI Number |
CTRI/2024/04/064992 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects and safety of of Injection Levetiracetam and Injection Magnesium Sulphate in the prevention of fits in pregnant women with high blood pressure |
|
Scientific Title of Study
|
A randomised control study to evaluate the safety and efficacy of Levetiracetam in comparison to Magnesium Sulphate in the management of severe pre-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 Rajasri G Yaliwal |
| Designation |
Professor |
| Affiliation |
BLDE(DU) Shri BM Patil Medical COllege, Hopsiyal and Research Center |
| Address |
Room NO 2
Department of OBG
BLDE(DU) Shri BM Patil medical college, Hopsital and Reasearch center, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasri G Yaliwal |
| Designation |
Professor |
| Affiliation |
BLDE(DU) Shri BM Patil Medical COllege, Hopsiyal and Research Center |
| Address |
Room NO 2
Department of OBG
BLDE(DU) Shri BM Patil medical college, Hopsital and Reasearch center, Vijayapura
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajasri G Yaliwal |
| Designation |
Professor |
| Affiliation |
BLDE(DU) Shri BM Patil Medical COllege, Hopsiyal and Research Center |
| Address |
Room NO 2
Department of OBG
BLDE(DU) Shri BM Patil medical college, Hopsital and Reasearch center, Vijayapura
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| BLDE(DU) Shri Bm Patil medical College, Hospital and Research Center, Vijayapura, Karnataka, India. PIN 586103 |
|
|
Primary Sponsor
|
| Name |
BLDE(DU) Shri BM Patil medical College, Hospital and Resarch Center, Vijayapura |
| Address |
Bangaramma Sajjan Campus, Solapur Road,Vijayapura, Karnataka, PIN586103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajasri G Yaliwal |
BLDE(DU) SHRI BM PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER |
Room No 2, Department of OBG,
BLDE(DU) SHri BM Patil Medical Colege, Hospital and research Center, Bangaramma Sajjan Campus Vijayapura PIN 586103
Bijapur
KARNATAKA |
9845152240
ryaliwal@bldedu.ac.in |
| Dr BH Narayani |
Koppal Institute of Medical sciences |
Deaprtment of OBG, Koppal Institute of Medical sciences, Koppal Near Kidadal Gate Gangavthi Road Koppal
PIN 583231
Koppal
KARNATAKA |
9738549650
bhnarayani@gmail.com |
| Dr Sunitha TH |
Shri Dharmasthala Manjunatheshwara College of Medical Sciences |
Department of OBG
SDM Medical College, Manjushree Nagar
Sattur
Dharwad - 580 009
Dharwad
KARNATAKA |
9740420913
srposdm@yahoo.com |
| Dr Geetanjali Katageri |
SN Medical College |
Department of OBG, SN Medical College,Navanagar Bagalkot
PIN 587102
Bagalkot
KARNATAKA |
9448776044
katagerigm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Koppal |
Approved |
| Institution Ethics Committee, SDM |
Approved |
| Institution Ethics Committee, SNMC |
Approved |
| Institution Ethics Committee,Vijayapura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
Loading dose: 500 mg twice daily (1000 mg/)day slowly over 5min intravenously.
The proposed regimen is to continue IV drugs for 24 hours then substitute oral levetiracetam 500mg bd for 5 days.
|
| Comparator Agent |
Magnesium Sulphate |
i. Loading dose: 4 g magnesium sulphate given IV over 3-5 mins followed by maintenance dose: 1gm/hour for 24 hour magnesium sulphate solution given in dilution via infusion pump |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women with gestational age of more than or equal to 28 weeks presenting with features of severe pre-eclampsia and/ or imminent eclampsia, needing immediate delivery as per treating clinician’s decision
2. No contraindication to either of the study drugs
3. Patients giving written informed consent for investigations and the proposed intervention
|
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with other causes of convulsions in pregnancy like cerebral malaria and epilepsy
2. Pregnant women with chronic hypertension without super-imposed pre-eclampsia
3. Pregnant females with fetal anomalies detected on USG
4. Pregnant women who already have deranged renal parameters
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effeciacy and safety of Levetiracetam in prevention of seizures in Preeeclampsia |
WIthin 30 min of administeting the drug. At 24 hours of administering the drug. At delivery of the baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of Levetiracetam and Magnesium sulphate |
For 5 days |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
14/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ryaliwal@bldedu.ac.in].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study should help the Women who are suffering from preeclampsia to have an alternative drug Levetiracetam for prevention of convulsions |