| CTRI Number |
CTRI/2025/07/091308 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two medications used to increase blood pressure, phenylephrine and norepinephrine, on contraction of uterus after caesarean delivery |
|
Scientific Title of Study
|
Effect of prophylactic infusions of phenylephrine and norepinephrine on uterine contractility and uterotonic requirements during elective caesarean section under spinal anaesthesia: A randomised double-blind comparison |
| 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 and Head |
| 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 |
mmohta@ucms.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor and Head |
| 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
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
mmohta@ucms.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surbhi |
| 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 |
8826643157 |
| Fax |
|
| Email |
surbhisauran007@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
mmohta@ucms.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research, 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: 1||Obstetrics, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine infusion |
Norepinephrine infusion will be started immediately after spinal anaesthesia and infusion rates will be titrated based on maternal systolic blood pressure |
| Comparator Agent |
Phenylephrine infusion |
Phenylephrine infusion will be started immediately after spinal anaesthesia and infusion rates will be titrated based on maternal systolic blood pressure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Consenting healthy mothers with term, uncomplicated, singleton pregnancy scheduled to undergo elective caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
History suggestive of maternal complications e.g., pre-eclampsia, cardiovascular disease, cerebrovascular disease
Known risk factors for postpartum haemorrhage e.g., multiple gestation, abnormal placentation, uterine fibroid, macrosomia, hydramnios, history of postpartum haemorrhage or uterine atony
Patients on monoamine oxidase inhibitors or tricyclic antidepressants
History suggestive of presence of mesenteric or peripheral vascular thrombosis
Patients with 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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total oxytocin dose requirement |
Intraoperative and 24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adequacy of uterine tone
Additional uterotonics used
Estimated blood loss
Fall in haemoglobin
Side effects of vasopressors and oxytocin
Incidence of postpartum haemorrhage
|
Intraoperative and 24 hours postoperative |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized, double-blind study will compare the effect of phenylephrine and norepinephrine on uterine contractility and uterotonic requirements during caesarean section in healthy consenting mothers with uncomplicated singleton, term pregnancy. One hundred and thirty consenting mothers undergoing caesarean section under spinal anaesthesia will be studied. After administration of spinal anaesthesia, phenylephrine or norepinephrine infusion will be titrated to maintain blood pressure. Oxytocin will be administered post-delivery, with dose adjustments and rescue uterotonics as needed. Oxytocin dose requirement, adequacy of uterine tone, additional uterotonics requirements, estimated blood loss, change in haemoglobin, incidence of postpartum haemorrhage and any side effects will be assessed. Intraoperative monitoring and postoperative follow-up for 24 hours will be conducted. Primary outcome will be oxytocin dose requirements. |