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CTRI Number  CTRI/2025/06/089589 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational pilot study 
Study Design  Other 
Public Title of Study   Larger Placentas and Blood Vessel Indicators Help Identify Risky Placenta Attachment in Pregnant Women 
Scientific Title of Study   Correlation of Placenta Accreta Score with Placental Volume and Angiogenic Markers 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Yadav  
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research  
Address  Department of Obstetrics and Gynaecology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9905514365  
Fax    
Email  dpkydv24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shalini Gainder 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research  
Address  Department of Obstetrics and Gynaecology, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9815555732  
Fax    
Email  sgainder@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepak Yadav  
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research  
Address  Department of Obstetrics and Gynaecology, PGIMER, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  9905514365  
Fax    
Email  dpkydv24@gmail.com  
 
Source of Monetary or Material Support  
This study is supported by the Department of Obstetrics and Gynaecology, PGIMER Chandigarh (160012), which provided funds for the ELISA kits. The research will be carried out within the same department at the Postgraduate Institute of Medical Education & Research, Chandigarh, India 
 
Primary Sponsor  
Name  Department of Obstetrics and Gynaecology PGIMER 
Address  Department of Obstetrics and Gynaecology, PGIMER, Chandigarh, India, 160012 
Type of Sponsor  Research institution and hospital 
 
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 Deepak Yadav  Post Graduate Institute of Medical Education and Research  Department of Obstetrics and Gynaecology, OPD room number 2032, ward Nehru level 3C block.
Chandigarh
CHANDIGARH 
09905514365

dpkydv24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, intramural  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O432||Morbidly adherent placenta,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Placenta Accreta Score group with age less than 40 years, POG more than 32 weeks, and features of accreta on the ultrasonography
control group with age less than 40 years,POG more than 32 weeks and at least 1 previous LSCS 
 
ExclusionCriteria 
Details  Women in both placenta accreta and control pregnancy group with hemoglobinopathies and other associated causes, multiple gestation, requiring urgent surgical intervention leaving inadequate time for evaluation and refusal to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
correlate placental volume and values of angiogenic markers (PlGF, SFLT, and, VEGF) with the placenta accreta score.   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
note the type of placental invasion assessed intraoperatively  12 months 
compare levels of hemoglobin & coagulation profile with the placental volume & angiogenic markers preoperatively & postoperatively among the women with placenta accreta & control group.  12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/07/2025 
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="6"
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  

In this observational study, we will recruit 40 pregnant women under 40 years of age, each at least 32 weeks gestational age and having had at least one previous cesarean section. Participants will be enrolled from the outpatient department or labor ward of the Obstetrics and Gynaecology Department at PGIMER after completing detailed history-taking, clinical examination, and ultrasound, and after providing informed consent. The study will commence only after receiving approval from the Institute Ethics Committee, with collaboration from the Departments of Radiodiagnosis and Pathology.

Exclusion criteria include hemoglobinopathies or other hematological disorders, multiple gestations, cases requiring urgent surgical intervention before complete evaluation, and individuals unwilling to participate.

The study cohort will consist of two equal groups:

Placenta accreta group: 20 women diagnosed using PAS scoring, at 32–36 weeks gestation (mean ~34 weeks).

Control group: 20 women with at least one prior cesarean section, at 32–40 weeks gestation (mean ~36 weeks).

Both groups will be matched for age, parity (gravida), and weight. Hematologic parameters will be collected at admission, on the day of surgery (day 0), and on post-operative day 2. Angiogenic markers will be measured on the day of delivery for all participants. Placental volume will be assessed at enrollment using 3D ultrasonography performed by an expert.

 
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