| CTRI Number |
CTRI/2024/03/064370 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
COMPARISON OF CAVAL AORTIC INDEX AND INFERIOR
VENACAVA COLLAPSIBILITY INDEX FOR PREDICTION OF POST
SPINAL HYPOTENSION IN PREGNANT FEMALES UNDERGOING
ELECTIVE CAESAREAN SECTION |
|
Scientific Title of Study
|
COMPARISON OF CAVAL AORTIC INDEX AND INFERIOR
VENACAVA COLLAPSIBILITY INDEX FOR PREDICTION OF POST
SPINAL HYPOTENSION IN PREGNANT WOMEN UNDERGOING
ELECTIVE CAESAREAN SECTION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GANGITE SANDHYA |
| Designation |
PG ANAESTHESIA |
| Affiliation |
|
| Address |
NEW DOCTORS HOSTEL,18TH FLOOR,ROOM NO:1815,B BLOCK,DR RML HOSPITAL,NEW DELHI,110001
CENTRAL
DELHI
INDIA
Central
DELHI
110001
India |
| Phone |
7093341131 |
| Fax |
|
| Email |
gangitesandhya249@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NISHA KACHRU |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
ABVIMS AND DR.RAM MANOHAR LOHIA HOSPITAL |
| Address |
ABVIMS AND DR.RAM MANOHAR LOHIA HOSPITAL
PGI BUILDNG,ROOM NO.305,3RD FLOOR,DEPARTMENT OF ANAESTHESIA,
CENTRAL
DELHI
110001
INDIA
Central
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
DR NISHA KACHRU |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
ABVIMS AND DR.RAM MANOHAR LOHIA HOSPITAL |
| Address |
ABVIMS AND DR.RAM MANOHAR LOHIA HOSPITAL
PGI BUILDNG,ROOM NO.305,3RD FLOOR,DEPARTMENT OF ANAESTHESIA,
CENTRAL
DELHI
110001
INDIA
Central
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
|
|
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 |
| GANGITE SANDHYA |
ABVIMS AND DR RML HOSPITAL,DELHI |
ABVIMS AND DR.RML HOSPITAL,BABA KHARAK SINGH MARG,NEAR GURUDWARA
BANGLA SAHIB,CONNAUGHT PLACE,NEW DELHI 110001
CENTRAL DELHI
INDIA
Central
DELHI |
7093341131
gangitesandhya249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RML Hospital New Delhi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasonographic measurement of caval aortic index and inferior vena cava collapsibility index in patients scheduled for elective caesarean section undergoing spinal anaesthesia |
With informed consent and after fulfilment of eligible criteria, patient will be taken on ot table and monitors will be attached. Then we measure caval aortic index and inferior vena cava collapsibility at max (expiration) and min (inspiration)
After giving spinal anaesthesia, we measure heart rate, systolic diastolic and mean arterial pressure every 3 min for the first 15 min and then every 5 minutes till delivery of the baby. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
SINGLETON PREGNANT WOMEN POSTED FOR ELECTIVE CAESAREAN SECTION.
MORE THAN 37 WEEKS OF GESTATION.
ASA CLASS II.
|
|
| ExclusionCriteria |
| Details |
BMI MORE THAN 30kg per meter square
MULTIPLE PREGNANCY
PATIENTS WITH UNCONTROLLED SYSTEMIC DISORDERS SUCH AS CARDIAC,RENAL OR HEPATIC DISEASES
PREGNANCY INDUCED COMPLICATIONS SUCH AS GESTATIONAL HYPERTENSION
BASELINE SYSTOLIC BP LESS THAN 90mmhg OR MEAN BP LESS THAN 70mmhg
PATIENTS IN WHOM MASSIVE INTRAOPERATIVE BLOODLOSS WAS EXPECTED EXAMPLE PLACENTA PREVIA OR ACCRETA
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Ultrasonographic measurement of IVCd(Inferior Vena cava diameter at the highest value)
2.Ultrasonographic measurement of IVCDmax (Inferior Venacava Diameter at the lowest value)
3.Ultrasonographic measurement of diameter of aorta
4.Measurement of heart rate, systolic,diastolic and mean arterial pressure (MAP) every 3min for the first 15min and then every 5 minutes till delivery of the baby.
|
1.Ultrasonographic measurement of IVCd(Inferior Vena cava diameter at the highest value)
2.Ultrasonographic measurement of IVCDmax (Inferior Venacava Diameter at the lowest value)
3.Ultrasonographic measurement of diameter of aorta
4.Measurement of heart rate, systolic,diastolic and mean arterial pressure (MAP) every 3min for the first 15min and then every 5 minutes till delivery of the baby.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/04/2024 |
| 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 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)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study to compare the caval aortic index and inferior vena cava collapsibility index for prediction of post spinal hypotension in pregnant women undergoing elective caesarean section to be conducted in ABVIMS AND DR RML HOSPITAL NEW DELHI, 110001. Sample size is 120. Primary objective is to compare the ultrasonographic measurement of caval aortic index and inferior vena cava collapsibility index for prediction of post spinal hypotension in pregnant women undergoing elective caesarean section. |