| CTRI Number |
CTRI/2025/12/098824 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
pre operative warming and maternal blood loss-evidence from cesarean section patients |
|
Scientific Title of Study
|
Effect of preoperative warming of parturients on blood loss during Cesarean section under spinal anesthesia: A Randomized Controlled Trial {HeAT-PS Hemorrhage Assessment after Thermoregulation in Parturient under Spinal anesthesia.} |
| Trial Acronym |
HeAT-PS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rapaka Lasyapriya Sivprasad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anesthesiology, AIIMS Nagpur, Dahegaon, Mihan
Nagpur MAHARASHTRA 441108 India |
| Phone |
8454020443 |
| Fax |
|
| Email |
lasya5400@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tanvi M Meshram |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anesthesiology, AIIMS Nagpur, Dahegaon, Mihan
Nagpur MAHARASHTRA 441108 India |
| Phone |
9968480167 |
| Fax |
|
| Email |
tanvimeshram162@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rapaka Lasyapriya Sivprasad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anesthesiology, AIIMS Nagpur, Dahegaon, Mihan
Nagpur MAHARASHTRA 441108 India |
| Phone |
8454020443 |
| Fax |
|
| Email |
lasya5400@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
AIIMS NAGPUR, mihan, dahegaon 441108 |
| Type of Sponsor |
Other [No monetary support will be needed] |
|
|
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 |
| rapaka lasyapriya sivprasad |
All India Institute of Medical Sciences |
Department of Anesthesiology, Department of Obstetrics and Gynecology IPD building, AIIMS Nagpur, Dahegaon,Mihan, 441108 Nagpur MAHARASHTRA |
8454020443
lasya5400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active prewarming group P |
The Active prewarming group P patients:
will receive 20 mins of active warming in the preoperative area, with a forced air warming device (IOB warming device) placed over the entire body and the thermostat of the forced-air warmer will be set at 43ºC.
10ml/kg preload of Ringer Lactate stored in a warming cabinet set at 40°C and delivered with fluid warming unit (KMS IV Fluid warmer) set at 40°C over 20 mins.
|
| Comparator Agent |
Control group C |
The control group C patients:
will be covered with warm cotton blanket.
No active warming in the preoperative area
Preloading with Ringer Lactate 10ml/kg stored at room temperature over 20 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All patients scheduled for elective cesarean section under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1.Contradiction to spinal anesthesia
2.Twin pregnancy
3.Placenta previa
4.Placenta accreta
5.Gestational hypertension/ pre-eclampsia
6.History of previous cesarean section
7.Conversion to general anesthesia
8.Coagulation disorders
9.Abruptio placenta
10.Polyhydramnios
11.Patients not giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the amount of intraoperative blood loss between the two groups. |
intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of hypothermia core temperature less than 36 degree celsius and shivering between two groups. |
T0 = baseline, T1 = pre-spinal, T2 = post-spinal, T3 = after 15 min in the OR, T4 =after 30min in the OR, T5 =surgery end, T6 = PACU arrival, T7 = after 30 min in the PACU, T8 = at discharge from the OR |
To compare patient comfort using verbal numerical scale.
|
T0 = baseline, T1 = pre-spinal, T2 = post-spinal, T3 = after 15 min in the OR, T4 =after 30min in the OR, T5 =surgery end, T6 = PACU arrival, T7 = after 30 min in the PACU, T8 = at discharge from the OR |
| To compare the neonatal outcomes (umbilical blood gas analysis and Apgar score at 1 and 5 min) |
1 minute and 5 minutes of life |
| 4. uterine tone |
intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="132" Sample Size from India="132"
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)
|
25/12/2025 |
| 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="7" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Summary
This randomized controlled trial investigates the impact of preoperative
warming on blood loss during cesarean section under spinal anesthesia. Cesarean
sections are increasingly common, with maternal hemorrhage a leading cause of
morbidity and mortality in India, particularly among anemic parturients. Spinal
anesthesia often causes vasodilation and hypothermia, exacerbating bleeding
risks. Preoperative warming has shown promise in minimizing these effects by
maintaining normothermia and improving coagulation.
The study hypothesizes that active prewarming can reduce intraoperative blood
loss, enhance thermal comfort, reduce shivering, and improve maternal and
neonatal outcomes. A total of 132 participants scheduled for elective cesarean
sections under spinal anesthesia will be enrolled at AIIMS Nagpur. They will be
randomly assigned to two groups: the Control Group (C), which will receive
standard care without active warming, and the Prewarming Group (P), which will
receive 20 minutes of forced-air warming and warm IV fluids.
The primary objective is to compare intraoperative blood loss between the
groups. Secondary objectives include evaluating the incidence of hypothermia
and shivering, assessing maternal thermal comfort, and measuring neonatal
outcomes (umbilical blood gas values and Apgar scores at 1 and 5 minutes).
Blood loss will be quantified using suction volumes, blood-soaked materials,
and postoperative hemoglobin changes. Core temperature will be monitored at
multiple time points, and thermal comfort and shivering will be graded using
established scales.
The study duration is 16 months, with ethical and CTRI approvals obtained prior
to initiation. Data will be analyzed using SPSS software, applying appropriate
statistical tests. This research aims to demonstrate that preoperative warming
is a simple, feasible intervention that can significantly improve safety and
outcomes for parturients undergoing cesarean sections under spinal anesthesia.
|