| CTRI Number |
CTRI/2024/06/068502 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the occurrence of fall in blood pressure after giving spinal anaesthesia in pregnant woman with high blood pressure and pregnant woman with normal blood pressure who are undergoing cesarean section. |
|
Scientific Title of Study
|
Comparison of the Haemodynamic Changes in Normotensive and Preeclamptic Pregnant Woman Posted for Cesarean Section Under Subarachnoid Block- Prospective Observational 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 Arun |
| Designation |
Junior resident in department of anaesthesiology and critical care |
| Affiliation |
Vijayanagar institute of medical sciences, Ballari |
| Address |
Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment, Ballari
Bellary KARNATAKA 583104 India |
| Phone |
8088822666 |
| Fax |
|
| Email |
arunv5656@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothsna M |
| Designation |
Professor |
| Affiliation |
Vijayanagar institute of medical sciences, Ballari |
| Address |
Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment, Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyothsna M |
| Designation |
Professor |
| Affiliation |
Vijayanagar institute of medical sciences, Ballari |
| Address |
Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment, Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar institute of medical sciences, Ballari |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
Vijayanagar institute of medical sciences, Cantonment, Ballari - 583104, Karnataka, India |
| 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 |
| Dr Arun |
Vijayanagar institute of medical sciences |
Room no. 99, Department of obstetrics and gynaecology, emergency operation theatre Bellary Bellary KARNATAKA |
8088822666
arunv5656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijayanagar institute of medical sciences,Ballari, Institutional ethics committee,VIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patients belonging to ASA 2 and 3 status, Patients scheduled for LSCS with normotensives or preeclampsia. |
|
| ExclusionCriteria |
| Details |
Patient refusal for spinal anaesthesia, history of allergy to drugs, any contraindications for spinal anaesthesia, pre-diagnosed eclampsia, HELLP syndrome, severe fetal distress, cord prolapse, twin pregnancy, antepartum hemorrhage, morbid obesity, pre-diagnosed chronic hypertension, diabetes mellitus, known cardiac disease, renal disease and coagulopathy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension |
After spinal anaesthesia every 2 minutes till initial 20 minutes there after every 5 minutes till end of the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grades of hypotension, Use of vasopressors, Use of oxytocis, Intravenous fluid requirement,Amount of blood loss |
After spinal anaesthesia every 2 minutes till initial 20 minutes there after every 5 minutes till end of the procedure.
After skin incision the blood loss shall be estimated till the end of surgery.
intra operative total dose of oxytocis used. |
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
15/06/2024 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
This
study will be conducted on pregnant
woman of ASA physical II (Normotensive) or III Preeclamptic(hypertension to the
extent of 140/90mmhg or more in two occasions 6hours apart with
proteinuria(more than 300 mg/24hours) after 20th week of pregnancy
in previously normotensive or non-protienuric patients), , carrying a live,
mature, healthy, single fetus scheduled for cesarean section under SAB.
Patients will be counselled during preoperative examination and will be recruited for this study after
obtaining informed consent from each of the patient in their own language.
Patients with chronic hypertension, diabetes mellitus, known cardiac disease,
renal disease, and coagulopathy; with contraindication to subarachnoid block,
known sensitivity to the study drugs and patients refusing to either regional
anesthesia or the study technique will also be excluded from the study. Any
patients showing signs or alarming symptoms for eclampsia will be excluded from
the study and managed with IV MgSO4 wherever indicated. All antihypertensives
will be continued till the day of surgery. After receiving the patient in the
operating room, documents will be checked, a brief clinical examination will be
done and standard ASA monitors will be attached including ECG, pulse oximetry
and temperature probe. Baseline heart
rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and
mean arterial pressure (MAP) will be recorded. After establishing IV access
with an 18G cannula 20 ml/kg lactated ringer solution (RL) will be administered
for prehydration. After proper aseptic precaution spinal subarachnoid block
(SAB) will be performed by an anesthesiologist, at L3-L4 intervertebral space
through a midline approach. Surgery will be allowed after adequate sensory and
motor block confirmed (T6 level). Immediately after delivery of head of the
baby oxytocin 5 IU will be administered over 1 minute followed by infusion at
the rate of 5 IU/H for 2 hours. Intraoperative blood loss of the mother will be
assessed from the drainage in suction bottles and checking the swabs and mops
used, clots and appropriate replacement done. HR, SBP, DBP and MAP will be
recorded every 2minutes for first 15minutes and every 5mintes after that
throughout the procedure. The data will
be labeled as group N for normotensives and group P for pre-eclamptics and will
be analyzed. |