| CTRI Number |
CTRI/2025/07/091307 [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 medicines used to increase blood pressure, phenylephrine and norepinephrine, on ability to form blood clot during caesarean delivery in patients who are thought to bleed more |
|
Scientific Title of Study
|
Comparison of effect of phenylephrine and norepinephrine on coagulation during caesarean section in parturients at high risk of postpartum haemorrhage : a 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 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
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
mmohta@ucms.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja |
| 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 |
8929777154 |
| Fax |
|
| Email |
pooja2709sharma@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 GTB 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: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine infusion |
Norepinephrine 4 microg per ml continuous infusion will be started IV immediately after spinal injection and then titrated based on systolic blood pressure until the end of surgery |
| Comparator Agent |
Phenylephrine infusion |
Phenylephrine 50 microg per ml continuous infusion will be started IV immediately after spinal injection and then titrated based on systolic blood pressure until the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Consenting mothers scheduled to undergo caesarean section under spinal anaesthesia with at least one of the following conditions:
Maternal age more than 35 years
Fetal malpresentation
Abnormal placenta
Previous uterine surgery
Uterine distension
Previous history of PPH
Multiple pregnancy
Uterine anomaly (Fibroid)
|
|
| ExclusionCriteria |
| Details |
History suggestive of bleeding or coagulation disorders
Use of anticoagulants or antiplatelet agents within 7 days of surgery
History suggestive of Infection, fever, or chorioamnionitis at time of delivery
Intrauterine death
Patients on monoamine oxidase inhibitors or tricyclic antidepressants
History suggestive of Presence of mesenteric or peripheral vascular thrombosis
Patients with absolute or relative contraindications for spinal anaesthesia
Previous history suggestive of thromboembolism and deep venous thrombosis
Hypertensive disorders of pregnancy
Known case of Antiphospholipid antibody syndrome, Systemic lupus erythematosus, autoimmune disorders
Assisted reproductive technology pregnancy
|
|
|
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 |
| Blood loss with prophylactic infusion of phenylephrine and norepinephrine in patients undergoing caesarean section under spinal anaesthesia |
Intraoperative and 24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Changes in haemoglobin levels
2) Coagulation parameters
3) Requirement of uterotonics
4) Requirement of blood transfusion
5) Complications, if any |
Intraoperative and 24 hours postoperative |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 aims to compare the effect of phenylephrine and norepinephrine infusions on coagulation during caesarean section in parturients at high risk of postpartum haemorrhage. Eighty consenting mothers undergoing caesarean section under spinal anaesthesia with risk factors such as advanced maternal age, abnormal placenta, multiple pregnancy, prior uterine surgery, previous history of PPH or uterine anomalies will be studied. Preoperative haemoglobin and coagulation parameters will be recorded. After administration of spinal anaesthesia, phenylephrine or norepinephrine infusion will be titrated to maintain blood pressure. Post-delivery, oxytocin will be administered, and total blood loss recorded. Haemoglobin and coagulation parameters will be reassessed in the postoperative period. The primary outcome will be total blood loss. |