| CTRI Number |
CTRI/2017/10/010009 [Registered on: 05/10/2017] Trial Registered Prospectively |
| Last Modified On: |
04/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MRI brain in pregnancy with hypertension |
|
Scientific Title of Study
|
Clinical and neuro-imaging correlates in hypertensive disorders of pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sweta Singh |
| Designation |
Assistant Professor, Obstetrics and Gynaecology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences (AIIMS) Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884131 |
| Fax |
|
| Email |
swetsingh@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta Singh |
| Designation |
Assistant Professor, Obstetrics and Gynaecology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences (AIIMS) Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884131 |
| Fax |
|
| Email |
swetsingh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweta Singh |
| Designation |
Assistant Professor, Obstetrics and Gynaecology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences (AIIMS) Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884131 |
| Fax |
|
| Email |
swetsingh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Grant 2017-18, All India Institute of Medical Sciences (AIIMS) Bhubaneswar, Sijua, Patrapada, Bhubaneswar 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Room No 409
Academic Block
AIIMS Bhubaneswar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sweta Singh |
AIIMS Bhubaneswar |
Labour ward, Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences (AIIMS) Bhubaneswar
Khordha
ORISSA |
9438884131
swetsingh@hotmail.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 |
Pregnancy with hypertension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women with a diagnosis of hypertensive disorder of pregnancy (pre-eclampsia, eclampsia, chronic hypertension, pre-eclampsia superimposed on chronic hypertension, gestational hypertension) will be recruited into the trial after obtaining consent. |
|
| ExclusionCriteria |
| Details |
Pregnant women with epilepsy, malaria, cerebral infections and metabolic disorders will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Co-relation of clinical, laboratory and neuro-imaging parameters in hypertensive pregnant women |
Upto 7 days postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal and foetal outcomes |
Upto 7 days postpartum |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/a |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertensive disorders of pregnancy are a known cause of adverse maternal and foetal outcomes. Various findings with magnetic resonance imaging (MRI) findings in pre-eclampsia & eclampsia include symmetrical occipital lesions suggestive of posterior reversible encephalopathy syndrome (PRES) and generalized vasospasm. Higher levels of lactate dehydrogenase (LDH) have been found in women with brain edema on MRI and also, other factors like serum aminoaspartate (AST) and diastolic blood pressure have been found to be predictive of MRI changes. However, very few studies are there which have attempted co-relation of all these parameters with neuro-imaging. Against this background, this current study will attempt to co-relate clinical and laboratory findings with neuro-imaging in women with hypertensive disorders of pregnancy, especially, pre-eclapmsia and ecmlapsia and also study the maternal and foetal outcomes during the hospital stay. |