| CTRI Number |
CTRI/2025/07/090764 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing a decrease in systolic versus mean arterial blood pressure for effect on well-being of babies born by cesarean delivery conducted under spinal anaesthesia. |
|
Scientific Title of Study
|
Postspinal Hypotension In Patients Of Preeclampsia: Randomised Comparison Of Equivalent Fall In Systolic Versus Mean Arterial Pressure For Effect On Neonatal Outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHA TYAGI |
| 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 GTB Hospital, Dilshad Garden, Shahadra
East DELHI 110095 India |
| Phone |
01122692415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
ASHA TYAGI |
| 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 GTB Hospital, Dilshad Garden, Shahadra
East DELHI 110095 India |
| Phone |
01122692415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shweta |
| Designation |
Postgraduate Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, Dilshad Garden, Shahadra
East DELHI 110095 India |
| Phone |
9996537541 |
| Fax |
|
| Email |
shwetagiroh66@gmail.com |
|
|
Source of Monetary or Material Support
|
| University college of Medical Sciences and GTB Hospital, Dilshad Garden, Shahdra, Delhi-110095. |
|
|
Primary Sponsor
|
| Name |
University College Of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Dilshad Garden, Shahadra, 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 |
| SHWETA |
University College of Medical Sciences and GTB Hospital |
2nd floor, OT block, Department of Anaesthesiology and Critical Care, Dilshad garden, Delhi. East DELHI |
09996537541
shwetagiroh66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research, (IED-HR), UCMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O14||Pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group M20: Postspinal hypotension defined as 20% or more fall in Mean blood pressure. |
Will be treated with boluses of vasopressor till blood pressure rises above the hypotensive threshold defined for group M20 (anytime from completion of spinal block upto delivery of baby). |
| Intervention |
Group S20: Postspinal hypotension defined as 20% or more fall in systolic blood pressure |
Will be treated with boluses of vasopressor till blood pressure rises above the hypotensive threshold defined for group S20 (anytime from completion of spinal block upto delivery of baby). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Consenting women with preeclampsia scheduled for cesarean section under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Those known with chronic hypertension and other cardaic vascular disease, cerebro vascular disease, known fetal abnormalities or any contraindications to spinal block |
|
|
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 |
| Umbilical artery pH |
At the time when baby is delivered (by cesarean section). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neonatal umbilical artery base excess |
At the time when baby is delivered (by cesarean section). |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
22/07/2025 |
| 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
|
The present study thus aims to compare two equivalent falls in systolic and mean arterial pressure for defining (and concomitantly treating) postspinal hypotension in patients of preeclampsia undergoing cesarean section, with regards to neonatal and maternal outcome. Primary objective is to compare postspinal hypotension defined as 20% or more fall in systolic blood pressure or in mean arterial pressure, in patients of preeclampsia undergoing cesarean section with regards to umbilical artery pH. Methods The anesthetic management for these patients will be standardized as per routine practice. This will include standardized aspiration prophylaxis, non-invasive monitoring and single-shot spinal block using hyperbaric bupivacaine. Systolic, diastolic and mean arterial pressures as well as heart rate will be measured every minute from the spinal injection until delivery of the baby. Hypotension after spinal anesthesia will be defined as a decrease in systolic arterial pressure of 20% or more from baseline for group S20; and similar fall in mean arterial pressure for group M20. Whenever postspinal hypotension occurs it will be treated with 50 microgm of phenylephrine (i.v.), repeated every minute, till the blood pressure rises above the hypotensive threshold. Statistical analysis will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Intergroup comparison will be done with Pearson’s Chi-square, Fisher’s exact test or Mann–Whitney U-test t-teat as appropriate, after testing for normal distribution using K-S test. Intergroup trends of arterial pressure and heart rate for the study period will be analyzed using mixed-model analysis, taking the best covariance structure based on Akaike’s information criterion (AIC). |