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CTRI Number  CTRI/2025/08/093673 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 25/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Risk factors of postpartum hemorrhage: A cross sectional study at a tertiary care centre 
Scientific Title of Study   The study of risk factors associated with PostPartum Hemorrhage : A Cross Sectional study in a teritiary care centre 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mallavolu Venkata Sai Naga Akhila 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College , Belagavi 
Address  G-1 labor room , department of Obstetrics and Gynaecology, KLES, Dr Prabhakhar Kore Hospital and Medical Research Centre, JNMC Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  07013881057  
Fax    
Email  akhilamvsn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Mrityunjay Chandrashekhar Metgud 
Designation  Professor, Department of Obstetrics and Gynaecology,JNMC 
Affiliation  Jawaharlal Nehru Medical College , Belagavi 
Address  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  09164693333  
Fax    
Email  metm67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mallavolu Venkata Sai Naga Akhila 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College , Belagavi 
Address  G-1 labor room , Department of Obstetrics and Gynaecology, KLES, Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  07013881057  
Fax    
Email  akhilamvsn@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr.Prabhakar Kore Hospital,JNMC 
 
Primary Sponsor  
Name  Mallavolu Venkata Sai Naga Akhila 
Address  Jawaharlal Nehru Medical College , Belagavi - 590010, Karnataka, 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 
DrMallavolu Venkata Sai Naga Akhila  KLES Dr. Prabhakar Kore Hospital ,JNMC  G-1 labor room , department of obstetrics and Gynaecology, KLES, Dr Prabhakhar Kore Hospital and Medical Research Centre, JNMC Belagavi
Belgaum
KARNATAKA 
07013881057

akhilamvsn@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: O720||Third-stage hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Age greater than or equal to 18 years of age.
2.All the pregnant women with greater than 28 weeks Period of gestation with delivery complicated by postpartum haemorrhage.
3.Women who provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Women with incomplete medical records or without reliable blood loss measurement data
2.Women who refuse or withdraw consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To indentify the risk factors associated with postpartum hemorrhage in a tertiary care centre  greater than 28 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal outcomes in deliveries complicated by postpartum hemorrhage  greater than 28 weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   15/09/2025 
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  

Introduction and Need for the study:

Postpartum hemorrhage continues to be one of the leading causes of maternal mortality and morbidity, accounting for about 19.7% all pregnancy related deaths worldwide . Primary PPH is typically defined as bleeding from Genital tract of 500 ml or more in first 24 hours of delivery of baby  blood loss of greater than 1000ml following Cesarean delivery of baby.

 The main causes or etiologies of post partum hemorrhage have traditionally been described as fourfold , giving the mnemonic 4 T’s ; Uterine atony( Tone), genital tract or surgical trauma (Trauma), retained placenta or parts of placental tissue(Tissue) and coagulopathies ( Thrombin). Most studies report Uterine atony or failure of the uterus to contract after delivery to be main cause of PPH.

 Late postpartum hemorrhage  is bleeding after 24 hours of delivery of baby. Severe morbidities associated with PPH include anemia, disseminated intravascular coagulation, blood transfusion, hysterectomy and renal or liver failure. Identifiable risk factors are believed to include: a history of prior PPH, nulliparity, overdistended uterus, placental abnormalities such as placenta previa or placenta accrete, coagulation abnormalities , anemia, induction of labor , augmentation of labor and prolonged labor.

Given increasing cesarean section rates and different risk factors reportedly associated with vaginal and cesarean births, it is worthwhile considering the outcomes following postpartum hemorrhage separately for these birth modes

 Despite advances in obstetric care, the condition remains unpredictable and often rapidly progressive. Tertiary care centres manage a high proportion of high risk pregnancies such as post partum hemorrhage making it essential to generate specific data. The rising incidence of Postpartum hemorrhage and very less Indian articles about the condition makes it essential to study.

 The main aim of my study is to identify the risk factors associated with PPH, maternal outcomes. Additionally we sought to describe the use of blood transfusions, medical and invasive management techniques commonly used to manage

Data collection procedure :

 Over a period of 12 months ,all the pregnant women with  greater than 28 weeks period of gestation whose pregnancies are complicated by postpartum hemorrhage admitted in labor room/ obstetric ward, Intensive care units, Emergency department of  KLE’s Dr. Prabhakar Kore Hospital, Belagavi  will be screened and included in the study after obtaining informed consent

 Measure the estimated blood loss or quantify it via validated method

Document vital signs such as blood pressure , pulse rate , respiratory rate and to note any ongoing signs of hemorrhage  Maternal characteristics include age, gravid, parity, gestational age at delivery , prior history of PPH, mode of delivery( vaginal or cesarean), any complications in previous delivery

   Detailed antenatal history and presenting complaints will be noted

  The general examination and detailed obstetrics examination ( uterine tone, presence of retained placental fragments or clots, presence of genital trauma etc 

    Maternal outcomes to Postpartum hemorrhage such as need for blood transfusion,  uterotonics,  uterine massage , surgical intervention) will be taken into accoun

    Baseline and post hemorrhage hemoglobin values to be compared

   Other routine investigations like Complete blood count, Urine routine and examination, serum thyroid stimulating hormone, DIPSI, HIV Status, HBsAg status, VDRL Status will be noted.

 
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