| 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
|
|
|
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
|
|
|
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. |