| CTRI Number |
CTRI/2024/05/066966 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study magnesium sulphate in patient with pregnancy with high blood pressure |
|
Scientific Title of Study
|
Randomised control trial for comparison of 12hours v/s 24 hours post-partum maintenance therapy of magnesium sulphate in severe pre- eclampsia and eclampsia patients’ |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sunita pandya |
| Designation |
Assistant professor |
| Affiliation |
PSMC karmsad anand |
| Address |
Pramukhswami medical college,obstetric and gynecological department
anand
pin 388325
Gujarat
Anand
GUJARAT
361008
India |
| Phone |
8094488479 |
| Fax |
|
| Email |
docsunitapandya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sunita pandya |
| Designation |
Assistant professor |
| Affiliation |
PSMC karmsad anand |
| Address |
Pramukhswami medical college,obstetric and gynecological department,karmsad
anand
pin 361008
Gujarat
GUJARAT
388325
India |
| Phone |
8094488479 |
| Fax |
|
| Email |
docsunitapandya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sunita pandya |
| Designation |
Assistant professor |
| Affiliation |
PSMC karmsad anand |
| Address |
Pramukh swami medical college,obstetric and gynecological department,karmsad
anand
pin 388325
Gujarat
anand
GUJARAT
388325
India |
| Phone |
8094488479 |
| Fax |
|
| Email |
docsunitapandya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Pramukhswami medical college |
| Address |
Pramukhswami medical college,obstetric and gynecological department,karmsad anand |
| Type of Sponsor |
Private medical college |
|
|
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 |
| dr Sunita pandya |
Pramukhswami medical college |
Praamukhswami medical college,obstetric and gynecological department,karmsad,Anand
Anand
GUJARAT |
8094488479
docsunitapandya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaikaka University,Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
pregnant women with severe pre eclampsia and eclampsia |
magnesium sulphate 4gm i.v followed by 1gm per hour intravenous infusion for 24hrs in severe pre eclampsia and eclampsia |
| Intervention |
pregnant women with severe pre eclampsia and eclampsia |
magnesium sulphate drug 4gm intavenous followed by maintenace dose 1gm per hour intavenous for 12 hours in severe pre eclampsia and eclampsia patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with severe pre-eclapsia and eclampsia admitted to OBGY department PSMC,karmsad |
|
| ExclusionCriteria |
| Details |
Status eclampicus
Renal compromise
Patient recieve other anti convulsant except magnesium sulphate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the recurrence of convlsions in patients receiving 12hrs/24hrs maintenance dose of magnesium sulphate |
To determine the recurrence of convlsions in patients receiving 12hrs/24hrs maintenance dose of magnesium sulphate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
maternal morbidity
Respiratory failure,ICU admission,total hospital stay,hospital acquired infection.
NEonatal outcome
first contact with mother,NICU admission,APGAR AT 5mins,neonatal morbidity |
baseline |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Magnesium sulphate is a drug of choice for severe pre eclampsia and eclampasia patients. As per standard protocol this drug is given as an loading dose 4gm inta venous followed by maintenance dose for 24 hours ,but this standard protocol is made by western country and we are also followed it. As our Indian women having weight less than western country so the need of dose is lesser in India. Many studies are done in India and are found significant.In this study loading dose of magnesium 4gm intavenous followed by maintennace dose 1gm per hour intravenous for a duration of 12hours instant of 24hrs by randomised control trial. |