| CTRI Number |
CTRI/2024/10/074858 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The relationship between abdominal measurements and intraoperative fall in blood pressure in pregnant women undergoing cesarean section under spinal anesthesia. |
|
Scientific Title of Study
|
Variations of symphysiofundal height and abdominal girth on blood pressure in parturients undergoing lower segment cesarean section under sub arachnoid block - A Double blind 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 |
Pallavi G |
| Designation |
Postgraduate student |
| Affiliation |
ESIC medical college & PGIMSR, Rajajinagar, Bangalore |
| Address |
Department of Anesthesia
2nd floor operation theater
ESIC Medical College and PGIMSR, Rajajinagar, Bengaluru.
Bangalore
KARNATAKA
560010
India |
| Phone |
8050795899 |
| Fax |
|
| Email |
pallavipujar21997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G B Sumalatha |
| Designation |
Professor |
| Affiliation |
ESIC medical college & PGIMSR |
| Address |
2nd floor operation theater
ESIC Medical college and PGIMSR, Rajajinagar,Bengaluru.
Bangalore
KARNATAKA
560010
India |
| Phone |
9538301443 |
| Fax |
|
| Email |
gbsumaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi G |
| Designation |
Postgraduate |
| Affiliation |
ESIC medical college & PGIMSR |
| Address |
2nd floor operation theater
ESIC Medical college and PGIMSR,Rajajinagar,Bengaluru.
Bangalore
KARNATAKA
560010
India |
| Phone |
8050795899 |
| Fax |
|
| Email |
pallavipujar21997@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and PGIMSR,Rajajinagar,Bengaluru,
karnataka,India.
pincode-560010 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College |
| Address |
ESIC Medical college and PGIMSR, Rajajinagar, Bengaluru, Pincode-560010
Karnataka.
Pincode-560010 |
| 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 Pallavi G |
ESIC medical college & PGIMSR |
Department of Anesthesia
2nd floor OT complex ESIC medical college & PGIMSR, Rajajinagar, Bengaluru, 560010.
Bangalore
KARNATAKA |
8050795899
pallavipujar21997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY PARTURIENTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient willing to provide informed consent
2.American society of Anesthesiology grade- 2
3.Weight 55-65kgs
4.Height 150-160cms
5. Preeclampsia without severe features
6. Blood pressure less than 160/90 mmhg |
|
| ExclusionCriteria |
| Details |
1.Parturient with severe pre eclampsia
2. Parturient with placenta previa, twin pregnancy, oligohydramnios or polyhydramnios, intrauterine growth retardation, ruptured membranes
3. Significant medical or obstretic morbidity
4. obrstructed labour
5. Abnormal lie and presentation
6.parturients with eclampsia
7. More than 3 previous cesarean deliveries
8. Multiple gestation
9.Parturients with bleeding disorder, on anticoagulants
10. Previous spine surgery
11. Gestational diabetes mellitus
12.Parturients with spine deformities
13. Body mass index more than 30kg/m2 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fall in blood pressure after sub arachnoid block |
At Baseline, 1min, 3min, 5min, 10min, 15min ,20min, 30min, 60min, 90min,120min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Highest level of sensory blockade after sub arachnoid block |
At 1min, 3min, 5min, 10min, 15min. |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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)
|
28/10/2024 |
| 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 double blind observational study to evaluate the fall in blood pressure and level of sensory block after sub arachnoid block at frequent intervals in a total of 73 parturients undergoing cesarean section. |