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CTRI Number  CTRI/2025/09/094824 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A longitudinal study to compare the amount of blood loss in pregnant women with term gestation undergoing caesarean section by using two different methods  
Scientific Title of Study   A longitudinal study to compare the amount of blood loss in caesarean section using QBL ( Quantitative Blood Loss ) v/s Modified Gross Formula 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyansha Raj 
Designation  Obstetrics and Gynaecology Junior Resident 
Affiliation  Jawaharlal Nehru medical College , KLE university Belagavi  
Address  Department of Obstetrics and Gynaecology, JNMC campus, Nehru nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8971813892  
Fax    
Email  priyansharaj08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M C Metgud 
Designation  Professor and Unit Head in Department of Obstetrics and Gynaecology  
Affiliation  Jawaharlal Nehru medical College , KLE university Belagavi  
Address  Jawaharlal Nehru Medical College, Nehru nagar Belagavi- 590010

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyansha Raj 
Designation  Obstetrics and Gynaecology Junior Resident 
Affiliation  Jawaharlal Nehru medical College , KLE university Belagavi  
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical colloge, Nehru nagar Belagavi- 590010

Belgaum
KARNATAKA
590010
India 
Phone  8971813892  
Fax    
Email  priyansharaj08@gmail.com  
 
Source of Monetary or Material Support  
KLEs Prabhakar Kore Charitable Hospital and Medical research centre, JNMC Campus, Nehru nagar, Belagavi- 590010 India  
 
Primary Sponsor  
Name  Priyansha Raj 
Address  Department Of Obstetrics and Gynaecology Jawaharlal Nehru Medical College, Nehru Nagar Belagavi-590010 India  
Type of Sponsor  Other [self] 
 
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 
Priyansha Raj  KLEs Prabhakar Kore Charitable Hospital and MRC   Department of Obstetrics and Gynaecology, JNMC campus nehru nagar Belagavi - 590010 India
Belgaum
KARNATAKA 
8971813892

priyansharaj08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O679||Intrapartum hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women with term gestation undergoing caesarean section at KLEs Prabhakar Kore Charitable Hospital and MRC Belagavi 
 
ExclusionCriteria 
Details  1. Women undergoing preterm caesarean section
2. Women with severe anaemia
3. History of anticoagulant usage
4. History of aspirin usage
5. Patients receiving blood transfusion within 48hours of section
6. Patients with severe pre-eclampsia and eclampsia
7. History of bleeding disorders  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the amount of blood loss in caesarean section by QBL (Quantitative Blood Loss) v/s Modified gross formula   Term gestation ( 37 weeks - 40weeks period of gestation ) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="298"
Sample Size from India="298" 
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)   26/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

        Globally, delivery by caesarean section ranks among the most common obstetric surgical procedures. Obstetric haemorrhage contributes significantly to maternal mortality and morbidity. An essential component of lowering morbidity during C- section is prevention and early recognition of blood loss through an effective means of measurement. The conventional methods of blood loss estimation often results in undiagnosed PPH. Despite, widespread use of haemoglobin and haematoicrit measurements, even in resource limiting settings, their application in estimating blood loss in obstetric care remains underutilize  In order to realize obstetric haemorrhage at an early stage, it is crucial that ongoing blood  loss should be accurately assessed. However, researchers have reported that obstetricians may underestimate blood loss and these underestimations may result in errors in making decisions about giving the patient blood or blood products.The underestimation of blood loss may result in inadequate fluid resuscitation, hypovolemia, shock, organ damage and impaired tissue oxygenation .Several studies conducted have shown a significant correlation between QBL and Modified gross formula in estimation of blood loss in vaginal deliveries. However, not sufficient evidence has been noted for the same in caesarean section, where the amount of blood loss estimated is often considered as a matter of debate due to traditional methods used for assessing the blood loss which lack accuracy.


     Data collection procedure

 

After approval from the Ethics Committee,patients will be screened for eligibility considering the inclusion and exclusion criteria and those patients who fit according to inclusion criteria will be recruited in the study.

 

Complete history will be collected from the medical record files including patient’s obstetric history at the time of admission and patients will be followed up to the date of discharge.

 

Pre- and post operative haemoglobin and haematocrit will be recorded

Pre-operative haematocrit being most recent within 1 week of C- section

Post – operative haematocrit will be measured 48 hours after section.

 

Blood loss will be calculated using 2 methods –

 

1.     Conventional methods – This will include the following -

 

- Gravimetric method- a Brasss V drape will be placed under buttocks of patient before starting the caesarean section and the amount of blood collected in the drape at the end of C- section will be recorded

 

- Suction canister – the process of quantification of blood loss will begin after the amniotic membrane is ruptured and baby is born. First suctioning of all the amniotic fluid will be done in one suction canister till the delivery of placenta.

After delivery of placenta blood will be suctioned in a different suction canister

 

- Soaked pads and gauze – weight of dry gauze and pads will be recorded. After section the weight of soaked pads and gauzes will be recorded where 1 gm weight will be taken as 1 ml of blood loss and the difference between the two weights would give an estimate of amount of blood loss

 

All these will be added to get the amount of blood loss by conventional method

 

2.     Modified gross formula –

 

- Haemoglobin and haematocrit values will be recorded prior to section and then repeated again after 48 hours of surgery

- Amount of blood loss will be calculated using this formula –

- Blood loss - Estimated BV X ( Hct pre-op – Hct post-op ) / Hct average

 

Where estimated blood volume will be taken as 70ml/kg

 

Blood loss estimation by both the methods will be compared

 
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