| CTRI Number |
CTRI/2024/01/062112 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the features of fetal anomalies found during the pregnancy and after the delivery. |
|
Scientific Title of Study
|
Antenatally detected Ultrasound Anomalies with Postnatal/Post Expulsion Correlation |
| 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 Rushali Pamnani |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical College Manipal |
| Address |
Department of Obstetrics and Gynecology
Kasturba medical College
Department of Obstetrics and Gynecology
Kasturba medical College
Madhavnagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9427287225 |
| Fax |
|
| Email |
pamnanirushali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa PS |
| Designation |
Additional Professor |
| Affiliation |
Kasturba medical College Manipal |
| Address |
Department of Obstetrics and Gynecology
Kasturba medical College
Madhavnagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008415729 |
| Fax |
|
| Email |
roopa.ps@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithesh Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical College Manipal |
| Address |
Department of Obstetrics and Gynecology
Kasturba medical College
Madhavnagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008897483 |
| Fax |
|
| Email |
nithesh.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Madhavnagar
Manipal
Udupi Karnataka |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
No sponsor |
| 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 Roopa Ps |
Kasturba Medical College |
Department of Obstetrics and Gynecology
Kasturba medical College
Madhavnagar Manipal
Udupi
KARNATAKA |
09008415729
roopa.ps@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical College and Kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O359||Maternal care for (suspected) fetal abnormality and damage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NILL |
NILL |
| Comparator Agent |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
SINGLETON pregnancy
Pregnant women with antenatally detected congenital anomalies. |
|
| ExclusionCriteria |
| Details |
Twin pregnancy
Pregnant women with normal Scan findings.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Postnatal follow up either post delivery or after expulsion. Fetal autopsy will be done in case of termination of pregnancy or still birth after consents. Depending on the structure involve postnatal follow up with Xray, ECHO, MRI will be done.
|
Time points: One day after delivery and 1 year after delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Postnatal findings with Antenatal findings of anomalies |
1 year |
|
|
Target Sample Size
|
Total Sample Size="720"
Sample Size from India="720"
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)
|
12/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
Purpose: To determine the prognosis of antenatally detected anomalies by Sonographic evaluation To illustrate the changing appearance of anomalies from prenatal to postnatal life and to correlate them. Design : Prospective Observational Descriptive Study Participants: Women with singleton pregnancy with fetus having Abnormal structural Scan findings Intervention: Antenatal routine ANC scans . Post expulsion/post delivery Fetal autopsy (in case of MTP or stillbirth ) Xray, ECHO, MRI in babies with antenatally detected anomalies Main Outcome Measures: The structural anomalies detected will be divided into 8 groups based on the systems involved like the Cardiovascular system, Central nervous system, Gastrointestinal, genitourinary, Skeletal system, Face and nape of neck, Respiratory system and others and correlation between antenatal scan findings and postnatal findings of Xray, ECHO, MRI or Fetal Autopsy will be done. |