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CTRI Number  CTRI/2025/10/096734 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   NIL 
Study Design  Other 
Public Title of Study   Keeping Mothers Safe: Finding the Causes and Prevention of Heavy Bleeding After Delivery" 
Scientific Title of Study   Assessment of risk factors and efficacy of multifaceted intervention to prevent primary Post Partum Hemorrhage among Pregnant women. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SEEMA SARKAR 
Designation  : Ph.D. Research Scholar, Nursing (OBG) Department of Nursing 
Affiliation  NAAC A GRADE, INDIAN NURSING COUNCIL 
Address  Teerthanker Mahaveer University, College of Nursing, Moradabad, Uttar Pradesh
Teerthanker Mahaveer University,College of nursing Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India 
Phone  8116345398  
Fax  05912360222  
Email  seema.scholar@tmu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  SEEMA SARKAR 
Designation  : Ph.D. Research Scholar, Department of Nursing 
Affiliation  Teerthanker Mahaveer University, Moradabad, Uttar Pradesh 
Address  Teerthanker Mahaveer University, Moradabad, Uttar Pradesh


UTTAR PRADESH
244001
India 
Phone  8116345398  
Fax  05912360222  
Email  seema.scholar@tmu.ac.in  
 
Details of Contact Person
Public Query  
Name  SEEMA SARKAR 
Designation  : Ph.D. Research Scholar, Department of Nursing 
Affiliation  Teerthanker Mahaveer University, Moradabad, Uttar Pradesh 
Address  Teerthanker Mahaveer University, Moradabad, Uttar Pradesh


UTTAR PRADESH
244001
India 
Phone  8116345398  
Fax  05912360222  
Email  seema.scholar@tmu.ac.in  
 
Source of Monetary or Material Support  
PRINCIPAL INVESTIGATOR Seema Sarkar Teerthanker Mahaveer University College Of Nursing Research Ph.d Scholar Moradabad U.P PIN-244001 
 
Primary Sponsor  
Name  PRINCIPAL NVESTIGATOR 
Address  Teerthanker Mahaveer University College of nursing Research Ph.D scholar Delhi Rad, Moradabad U.P 244001  
Type of Sponsor  Private medical college 
 
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 
Dr Rashmi Agnihotri  NBMCH  MEDICAL COLLEGE DEPARTMENT STREET/AREA-D5 QUARTER SUSRUTA NAGAR DARJEELING SILIGURI-734012
Darjiling
WEST BENGAL 		 7018781505
0591-2360222
rashmiagnihotri.nursing@tmu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Teerthanker Mahaveer University Level Research Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mutifaceted intervention (structured teaching program)  Introduction to PPH Causes and Risks Recognizing PPH Danger Signs Birth Preparedness and Complication Readiness (BPCR) Nutrition & IFA counseling B.P and Hemoglobin monitoring Postpartum Self-Care  
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women between 16 to 28 weeks of gestation
Pregnant women may be primigravida or multigravida
Low to moderate PPH risk Age multiparty mild anemia Malnutrition mild Gestational Hypertension
Willing to participate and available for data collection.
Women who provide informed consent to participate in the study or intervention
 
 
ExclusionCriteria 
Details  High-Risk Cases: Women identified as high-risk for PPH those with a history of
PPH placenta previa or placental abruption Previous Caesarean section deliver
Women who do not provide informed consent
Women who are not willing to participate. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is the improvement in knowledge and preparedness regarding the prevention and early recognition of primary postpartum hemorrhage among antenatal mothers. This will be measured using a structured knowledge questionnaire administer afterthe educational intervention.   At 16-28 weeks of gestation
•One day 10 samples are selected and then to be continued for the rest days till 200 samples
•10 samples each day 20 days for 200 sample selection
•On same day educational intervention
•Then administer structured knowledge questionnaire on same day

At 32-38 weeksgroup discussion with completion of Participant
Feedback form to evaluate efficacy of intervention around 20 mothers each day so 10 days for 200 mother.

 
 
Secondary Outcome  
Outcome  TimePoints 
reduce MMR in pph mother
prevalence after intervention  		 06 month 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="200" 
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)   30/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/12/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [seema.scholar@tmu.ac.in].

  6. For how long will this data be available start date provided 13-11-2025 and end date provided 30-06-2027?
    Response (Others) -  beginning 1 month and ending 6 months

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Post partum haemorrhage is the leading cause of  maternal death and largely preventable through  antenatal  care.This study evaluates a multifaceted intervention combining education and risk assessment to improve knowledge and preparedness thereby enhancing maternal awareness and preventing Primary Post partum Haemorrhge. 
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