| CTRI Number |
CTRI/2024/02/063264 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examining the link between ultrasound measured eye nerve size and the timing of discontinuing magnesium sulphate treatment in pre-eclamptic patients with severe features – A preliminary observation study |
|
Scientific Title of Study
|
To study the correlation between ultrasound guided optic nerve sheath
diameter measurements with respect to timing of stopping of magnesium sulphate therapy, in
pre-eclamptic patients with severe features – a prospective, observational, pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Subudhi |
| Designation |
Post-Graduate Junior Resident |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Anaesthesiology, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8598989789 |
| Fax |
|
| Email |
rakeshsubudhi88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Ramchandani |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Anaesthesiology, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9424204244 |
| Fax |
|
| Email |
drsaritaramchandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Ramchandani |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Anaesthesiology, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9424204244 |
| Fax |
|
| Email |
drsaritaramchandani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Rakesh Subudhi |
All India Institute Of Medical Sciences, Raipur |
Department of Anaesthesiology and Department of Obstetrics and Gynaecology
Raipur
CHHATTISGARH |
8598989789
rakeshsubudhi88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patients aged ≥18 years
Period of gestation ≥ 20 weeks
Presenting with pre-eclampsia with severe features
Patients who will receive MgSO4 therapy
Planned for termination of pregnancy |
|
| ExclusionCriteria |
| Details |
Patient’s refusal
Eclamptic patients
Patient who receives MgSO4 prior to first reading of optic nerve sheath diameter.
Patients who have undergone previous cranial or eye surgeries
Patients suffering from seizures, intracranial or eye pathology, glaucoma or any other
neurological condition.
Patients with uncontrolled diabetes or cardiac disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A high optic nerve sheath diameter value (≥ 5.8 mm) is expected in patients presenting with pre-eclampsia with severe features at various time points in the post natal period even after stopping of MgSO4 therapy. |
Ultrasound guided optic nerve sheath diameter assessment will be done prior to start of MgSO4 therapy and baseline value will be noted. Thereafter, ultrasound guided optic nerve sheath diameter assessment will be done at 6 hour time point after
starting of MgSO4. Subsequent values will be noted immediately after delivery and thereafter at 12 hour, 24 hour and 48 hour time point after delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
All eligible patients will be explained about the study. Baseline ultrasound guided optic nerve sheath diameter will be recorded prior to starting of MgSO4, date and time of starting MgSO4 will be noted .Subsequently optic nerve sheath diameter will be measured after 6 hours of starting MgSO4 therapy , thereafter immediately after delivery and thereafter 12 hours, 24 hours and 48 hours after delivery. Date and timing of stopping of MgSO4 will be noted. A high ONSD value (≥ 5.8 mm) is expected in patients presenting with pre-eclampsia with severe features at various time points in the post natal period even after stopping of MgSO4 therapy. |