| CTRI Number |
CTRI/2016/03/006762 [Registered on: 23/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
23/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Short duration magnesium sulphate therapy in cases of severe hypertension in pregnancy |
|
Scientific Title of Study
|
POST PARTUM SEIZURE PROPHYLAXIS WITH SHORT COURSE MAGNESIUM SULFATE THERAPY IN SEVERE PREECLAMPSIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1180-1191 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAHEEN ANJUM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JNMCH, AMU, aligarh |
| Address |
Department of Obstetrics and Gynecology, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
|
| Fax |
|
| Email |
shahanjum73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHAHEEN ANJUM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JNMCH, AMU, aligarh |
| Address |
Department of Obstetrics and Gynecology, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9319861442 |
| Fax |
|
| Email |
shahanjum73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRAMOD GADE RAJARAM |
| Designation |
POST GRADUATE |
| Affiliation |
JNMCH, AMU, aligarh |
| Address |
Department of Obstetrics and Gynecology, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
|
| Fax |
|
| Email |
pramodgade8@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
SHAHEEN ANJUM |
| Address |
Associate professor
department of obstetrics and gynaecology,
JNMCH, AMU, Aligarh |
| 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 |
| SHAHEEN ANJUM |
JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL |
Labor room, department of obstetrics and gynaecology
JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH |
9319861442
shahanjum73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Severe pre eclampsia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Magnesium sulfate 4 gm loading dose followed by infusion 1 gm per hour for 24 hours post delivery |
| Intervention |
Study group |
Magnesium sulfate 4 gm loading dose followed by infusion 1 gm per hour till delivery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all antenatal women with severe pre eclampsia |
|
| ExclusionCriteria |
| Details |
Eclampsia
complicated severe pre eclampsia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of convulsions |
From admission till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dose of magnesium sulfate used, duration of foleys catheterisation, duration of hospital stay, |
Mg, hours, day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2012 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims to study the efficacy of short duration of magnesium sulfate in cases of severe pre eclampsia |