| CTRI Number |
CTRI/2018/07/014890 [Registered on: 16/07/2018] Trial Registered Prospectively |
| Last Modified On: |
14/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational hospital based study. |
| Study Design |
Other |
|
Public Title of Study
|
Clinical and Radiological profile of disease of cerebrovascular system in hypertensive disease of pregnancy |
|
Scientific Title of Study
|
Clinicoradiological profile of cerebrovascular disease in hypertensive disease 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 |
DrDivya Soin |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and hospital,Faridkot |
| Address |
Department of Medicine,
Guru Gobind Singh Medical College and hospital Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
7814422672 |
| Fax |
|
| Email |
divyasoin12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDivya Soin |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and hospital,Faridkot |
| Address |
Department of Medicine,
Guru Gobind Singh Medical College and hospital Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
7814422672 |
| Fax |
|
| Email |
divyasoin12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JATINDER KOCHHAR |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College and hospital,Faridkot |
| Address |
Department of Medicine,
Guru Gobind Singh Medical College and hospital Faridkot.
Faridkot
PUNJAB
152003
India |
| Phone |
8146527696 |
| Fax |
|
| Email |
dr.jatinderkochhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical College and hospital,Faridkot |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Government 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 |
| DrDivya Soin |
Guru Gobind Singh Medical College and Hospital,Faridkot |
Guru Gobind Singh Medical College and Hospital,Faridkot
Faridkot
PUNJAB |
7814422672
divyasoin12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical commitee,Guru Gobind Singh Medical College and Hospital ,Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Peripartum females with history of hypertension., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Peripartum females with history of hypertension |
|
| ExclusionCriteria |
| Details |
1.Patients with history of any systemic illness.
2.Patients with history of any benign or malignant neoplasm involving central nervous system.
3.Patients with cardiac pacemaker or in which MRI is contraindicated.
4.Patients who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
cerebral oedema
ischemia
haemorrhage |
30 min
45min
60min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
cerebral venous thrombosis.
posterior reversible cerebral vasoconstriction syndrome.
Subarachnoid haemorrhage.
|
30min
45min
60min |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/07/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertensive disease of pregnancy,also known as maternal hypertensive disorder is a group of diseases that include preeclampsia,eclampsia.gestational hypertension and chronic hypertension.Maternal hypertensive disorders occurred in about 20.7 million women in 2013.About 10% of pregnancies globally are complicated by hypertensive diseases.They are one of the three major causes of death in pregnancy (16%) alongwith post partum bleeding (13%) and puerperial infections(2%). A total of 50 patients will be selected after meeting the inclusion criteria. A detailed history will be taken and clinical examination will be done. Obstetric data such as parity, antenatal care, gestational age at the onset of stroke, and the presence of complications like PET , eclampsia, anemia, and sepsis will be noted. The following investigations will be carried out on all patients: complete hemogram, platelet count, Mean platelet volume, and renal functions test. Fundus examination will be done.The CT scan will be done on 128 slice Siemens perspective AS model. Three arterial sections will be taken. MRI scan will be done on Siemens Avanto system. T1W, T2W, FLAIR, and DWI/ADV and SWI axial and coronal sequences will be done with 3 mm slice thickness. MR venogram ant MR Angiography will be done if required. CT will be done for postpartum patients. MRI will be done for antepartum patients. Patients will not bear the cost of CT/MRI if it is done solely for study/research purpose. Statistical analysis All the recorded data will be noted on excel sheet and will be analysed by appropriate stastical tests. |