| CTRI Number |
CTRI/2019/08/020951 [Registered on: 28/08/2019] Trial Registered Prospectively |
| Last Modified On: |
07/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Ultra sonographic changes of Optic Nerve Sheath Diameter in Severely pre-eclamptic patients treated with Magnesium Sulphate |
|
Scientific Title of Study
|
Ultra sonographic changes in Transorbital measurement of Optic Nerve Sheath Diameter in a Magnesium Sulphate Treated Severely pre-eclamptic patients : A Prospective observational study |
| Trial Acronym |
ONSD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1238-9565 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KANCHAN RANI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TEERTHANKAR MAHAVEER MEDICAL COLLEGE |
| Address |
ROOM NO 4,oBSTERICS ICU GROUND FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY TEERTHANKAR MAHAVEER MEDICAL COLLEGE BAGADPUR
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
07017621406 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Associate Professor |
| Affiliation |
TEERTHANKAR MAHAVEER MEDICAL COLLEGE |
| Address |
ROOM NO 2 2nd FLOOR DEPARTMENT OF ANAESTHESIOLOGY TEERTHANKAR MAHAVEER MEDICAL COLLEGE BAGADPUR
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Associate Professor |
| Affiliation |
TEERTHANKAR MAHAVEER MEDICAL COLLEGE |
| Address |
ROOM NO 2 2ND FLOOR DEPARTMENT OF ANAESTHESIOLOGY TEERTHANKAR MAHAVEER MEDICAL COLLEGE BAGADPUR
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TEERTHANKAR MAHAVEER MEDICAL COLLEGE |
| Address |
ROOM NO 4 OBSTERICS ICU GROUND FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY TEERTHANKAR MAHAVEER MEDICAL COLLEGE BAGADPUR |
| 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 |
| Kanchan Rani |
TEERTHANKAR MAHAVEER MEDICAL COLLEGE |
ROOM NO 4,OBSTERICS ICU GROUND FLOOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY TEERTHANKAR MAHAVEER MEDICAL COLLEGE BAGADPUR
Moradabad
UTTAR PRADESH |
07017621406
drkanchanrani@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 |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Optic Nerve Sheath Diameter measurement in severe preeclamptic patient |
Procedure ONSD Measurement
Patient will be in supine position
7 and 15 MHz Linear array transducer will be used
Transducer is applied directly to closed eyelid following application of a thick gel layer
Transducer is positioned horizontally over upper aspect of eyeball
Excessive pressure was avoided with gentle handling,
The probe will be adjusted to display the entry of the optic nerve into the globe with the ONSD width perpendicular to the vertical axis of the scanning plane ,in the 2-dimensional mode.
After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper.
The final ONSD value was calculated by averaging 2 measured values in transverse plane of both eyes.
The measurements above 5 mm will be considered to have increased ICP
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients giving written informed consent,
Antenatal patient diagnosed to have severe pre-eclampsia
Patient about to receive Magnesium Sulphate therapy. |
|
| ExclusionCriteria |
| Details |
Chronic hypertension
Hyperthyroidism
High myopicPresence of ocular wound
Prior ocular surgery
Presence of oliguria and deranged KFT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Optic nerve sheath diameter will be measuremed transorbitally by ultrasound in severe preeclamptic patient and will be compared with optic nerve sheath diameter at different time intervals after administration of MgSO4 treatment. |
just prior to start of MgSO4 therapy and at 2hr, 4hr, 6hr,12hrs and 24 hrs after start of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes following MgSo4 theray
Neurological signs and symptoms before and following MgSO4 therapy.
Incidence of raised ICP in severe pre-eclampsia prior to and after MgSO4 therapy.
|
just prior to start of MgSO4 therapy and at2hr, 4hr, 6hrs,12hrs and 24 hrs after start of therapy. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2019 |
| Date of Study Completion (India) |
31/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Preeclampsia is one of the most common serious medical disorder of human pregnancy, complicating around 3-4% of pregnancies worldwide and it remains a leading cause of maternal mortality many such deaths being attributable to the sequelae of this condition mainly neurological events, such as eclampsia and intracranial hemorrhage along with acute pulmonary oedema and hepatic rupture. Again, it is the neurological complications of this condition that result in most of the morbidities , including blindness, persistent neurological deficits secondary to stroke, and later cognitive impairment. The newborns are also susceptible to neurological,cardiovascular and metabolic diseases in later life. Clinical signs of raised intracranial pressure (ICP) are not specific and often present late and are difficult to interpret during pregnancy and preeclampsia. The actual incidence of raised ICP in preeclampsia and eclampsia is unknown. The gold standard method for ICP measurement isbased on invasive devices which is often not feasible in pregnancy. Many studies had suggested that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) can give a fair idea of raised ICP especially in neurocritical care such as stroke, meningitis ,CNS trauma,and epilepsy. Magnesium Sulphate (MgS04) has been used since ages in obstetrics for the prevention and treatment of seizures in pre-eclamptic and eclamptic parturients. However its effect on raised ICP is still unclear. Assuming OSND as a surrogate marker for raised ICP we evaluated effect of MgSO4 on ONSD and hence raised ICP . |