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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  
nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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