| CTRI Number |
CTRI/2024/12/077671 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
maternal and perinatal outcomes in placenta accreta spectrum disorders - A retrospective observational study |
|
Scientific Title of Study
|
maternal and perinatal outcomes in placenta accreta spectrum disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MB Bellad |
| Designation |
professor |
| Affiliation |
jawaharlal nehru medical college,belagavi,prabhakar kore charitable hospital |
| Address |
Department of obstetrics and gynaecology ,KAHERs Dr. Prabhakar Kore Charitable Hospital, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sneha Chakraborty |
| Designation |
postgraduate student |
| Affiliation |
jawaharlal nehru medical college,belagavi,prabhakar kore charitable hospital |
| Address |
Room number 513 , New PG Girls hostel , JNMC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7064266723 |
| Fax |
|
| Email |
snehawesome@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MB Bellad |
| Designation |
professor |
| Affiliation |
jawaharlal nehru medical college,belagavi,prabhakar kore charitable hospital |
| Address |
Department of Obstetrics and Gynaecology, KAHERs Dr. Prabhakar Kore Charitable Hospital, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology, JNMC, KLES Dr. Prabhakar Kore Charitable Hospital, Belagavi, Karnataka, PIN - 590010 , India |
|
|
Primary Sponsor
|
| Name |
Dr MB Bellad |
| Address |
KAHERs Dr. Prabhakar Kore Charitable Hospital , Belagavi |
| Type of Sponsor |
Other [self] |
|
|
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 MB Bellad |
KLEs Dr. Prabhakar Kore Charitable Hospital,JNMC |
KLEs Dr. Prabhakar Kore Charitable Hospital, JNMC, Belagavi, 590010, India
Belgaum
KARNATAKA |
09448124893
mbbellad@hotmail.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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal females under the age group 18-35 diagnosed with placenta accreta spectrum disorders |
|
| ExclusionCriteria |
| Details |
All antenatal females under the age group 18-35 not diagnosed with placenta accreta spectrum disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the maternal outcomes |
to study the maternal outcomes from the period of 1st jan 2020- 1 st august 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the perinatal outcomes |
to study the perinatal outcomes from 1st jan 2020 - 1st august 2024 |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
10/12/2024 |
| 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="4"
Months="0"
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 - NO
|
|
Brief Summary
|
it is a retrospective study based on the cases that have been reported and diagnosed with placenta accreta spectrum disorder and to study the maternal and perinatal outcomes from the period of 1st jan 2020 - 1st august 2024. The purpose of the trial is to study the fetomaternal outcomes in patients diagnosed with placenta accreta spectrum which will help in improving the diagnosis , management and prevention of complications in future. |