| CTRI Number |
CTRI/2024/05/066927 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of a continuous drip or new method of giving several small injections, of the medicine, phenylephrine, to prevent fall in BP, during caesarean delivery |
|
Scientific Title of Study
|
Comparison of a modified regimen of prophylactic phenylephrine boluses versus variable rate infusion during elective caesarean section under spinal anaesthesia: a non-inferiority randomised 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 |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College Of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College Of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sorabh Anchal |
| Designation |
Post Graduate Student |
| Affiliation |
University College Of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9813623130 |
| Fax |
|
| Email |
sorabh2311@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095 |
| 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 Medha Mohta |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
Department of Anaesthesiology and Critical Care, 2nd Floor OT Block
East
DELHI |
9868399626
medhamohta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research (IEC-HR), University College of Medical Sciences, University of Delhi, Delhi -110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bolus Group |
Prophylactic bolus of 100mcg phenylephrine will be given after spinal block and repeat doses will be given to maintain systolic blood pressure near baseline values till the time of delivery of baby |
| Comparator Agent |
Infusion group |
Prophylactic intravenous variable rate infusion of phenylephrine starting at 50 mcg/min and titrated according to Systolic blood pressure till the time of delivery of baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Healthy mothers with term, uncomplicated, singleton pregnancy scheduled to undergo elective caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Maternal complications e.g., pre-eclampsia, cardiovascular disease, cerebrovascular
disease, Multiple gestation, Placental complications, Known fetal abnormality, absolute or relative contra-indications for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of physician interventions |
delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Phenylephrine requirements
2. Number of episodes of hypotension, reactive hypertension, bradycardia or arrhythmias
3. Umbilical arterial and venous blood gas analysis
4. Apgar scores at 1 and 5 minutes
5. Incidence of nausea, vomiting, dizziness, or any other maternal complication
|
Delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/05/2024 |
| Date of Study Completion (India) |
08/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| 80 healthy mothers with term, uncomplicated, singleton pregnancy scheduled to undergo elective caesarean section under spinal anaesthesia will be given either prophylactic intravenous variable rate infusion of phenylephrine titrated according to systolic blood pressure or prophylactic bolus of phenylephrine immediately after spinal anaesthesia and then whenever systolic blood pressure falls to below 90% of baseline. Umbilical arterial and venous blood samples of the fetus will be obtained from a segment of umbilical cord for blood gas analysis. Primary outcome measure will be number of physician interventions. |
|