| CTRI Number |
CTRI/2023/04/051619 [Registered on: 13/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Reasons responsible for complications in a convulsing pregnant women |
|
Scientific Title of Study
|
Factors associated with severe maternal outcome (SMO) among women with eclampsia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth N R |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology , JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500146616 |
| Fax |
|
| Email |
prashanthravi12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip Kumar Maurya |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology , JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442136037 |
| Fax |
|
| Email |
dilipkumar@jipmer.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prasanth N R |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology , JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500146616 |
| Fax |
|
| Email |
prashanthravi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute Of Postgraduate Medical Education and Research
JIPMER Campus road ,
JIPMER Campus , Dhanvantari Nagar,
Puducherry -605006 |
|
|
Primary Sponsor
|
| Name |
Prasanth N R |
| Address |
Jawaharlal Institute Of Postgraduate Medical Education and Research
JIPMER Campus road ,
JIPMER Campus , Dhanvantari Nagar,
Puducherry -605006 |
| 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 |
| PRASANTH N R |
Jawaharlal Institute Of Postgraduate Medical Education and Research JIPMER |
Department of obstetrics and gynaecology
Women and children health care block
OG ICU /Casualty/ Eclampsia room
JIPMER Campus road ,
JIPMER Campus , Dhanvantari Nagar,
Puducherry -605006
Pondicherry
PONDICHERRY |
9500146616
prashanthravi12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIP/IEC-OS/2022/381 .INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES JIPMER |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Eclampsia is defined by new-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use |
|
| ExclusionCriteria |
| Details |
Pregnant women who is
1) Known case of epileptic disorder
2) Drug toxicity
3) Infective causes of seizures - meningitis, encephalitis, granuloma, tuberculoma
4) Space occupying lesions of brain
5) Hyperpyrexia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the risk factors associated with severe maternal outcome (SMO). |
at baseline , at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the maternal and perinatal outcome. |
at baseline , at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Eclampsia cases reflect the quality of medical care in a population. There is paucity of data from southern part of the country. This study will help us to know the factors associated with severe maternal outcome (SMO) among women with eclampsia. This study will help us to identify, prognosticate and plan preventive strategies based on the risk factors and provide better care to patients in future and improve the pregnancy outcome. This is an ambispective study which includes collection of data of patients from january 2017 till december 2024 for period of 8 years. We plan to recruit a minimum of 300.
|