| CTRI Number |
CTRI/2024/03/064640 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ANTENATAL USG SCAN] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
FETAL KIDNEY LENGTH TO DETERMINE GESTATIONAL AGE ESTIMATION IN 3RD TRIMESTER OF PREGNANCY |
|
Scientific Title of Study
|
FETAL KIDNEY LENGTH AS A PARAMETER FOR GESTATIONAL AGE ESTIMATION IN THIRD TRIMESTER AND ITS COMPARATIVE EVALUATION WITH OTHER FETAL BIOMETRIC INDICES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharmeshkumar j patel |
| Designation |
junior resident |
| Affiliation |
Junior Resident |
| Address |
department of obstetrics and gynecology, JNMC , Wardha , Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8866556625 |
| Fax |
|
| Email |
dharmesh1303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. KAMLESH CHAUDHARI |
| Designation |
PROFESSOR |
| Affiliation |
MBBS, MD |
| Address |
Department of Obstetrics and Gynaecology , JAWAHARLAL NEHRU MEDICAL COLLEGE,Sawangi , Wardha
Department of Obstetrics and Gynaecology , JAWAHARLAL NEHRU MEDICAL COLLEGE,Sawangi , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9320568673 |
| Fax |
|
| Email |
DR.KAMLESHCHAUDHARI@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dharmeshkumar j patel |
| Designation |
junior resident |
| Affiliation |
resident, acharya Vinoba Bhave rural hospital,dmiher,sawangi,wardha. |
| Address |
10,meghe heights , JNMC, Sawangi, wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8866556625 |
| Fax |
|
| Email |
dharmesh1303@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, JNMC |
|
|
Primary Sponsor
|
| Name |
Dharmesh Patel |
| Address |
JNMC, Sawangi (Meghe), Wardha, Maharashtra |
| 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 |
| DHARMESH |
ACHARYA VINOBA BHAVE HOSPITAL |
DEPARTMENT OF OBGY,SAWANGI WARDHA
Wardha
MAHARASHTRA |
8866556625
DHARMESH1303@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHIC COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PREGNANT WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANC USG |
ANC USG |
| Comparator Agent |
On USG
Abdominal Circumference
|
On USG we will estimate gestational age by calculating Mean kidney length and compare it with gestational age estimation using Abdominal Circumference |
| Comparator Agent |
On USG Femur Length |
On USG we will estimate gestational age by calculating Mean kidney length and compare it with gestational age estimation using Femur Length |
| Comparator Agent |
On USG Head Circumference |
On USG we will estimate gestational age by calculating Mean kidney length and compare it with gestational age estimation using Head Circumference |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ANTENATAL SCAN OF THIRD TRIMESTER PREGNANT WOMEN |
|
| ExclusionCriteria |
| Details |
NON PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GESTATION AGE OF PREGNANT WOMAN |
THIRD TRIMESTER i.e. 28 weeks - 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This thesis explores the potential of fetal kidney length as a parameter for estimating gestational age during the third trimester of pregnancy. The study involves a comparative evaluation with other established fetal biometric indices commonly used for gestational age estimation. The research aims to determine the accuracy and reliability of fetal kidney length as a novel predictor, which could potentially improve current methods of estimating gestational age in late-stage pregnancies. By analyzing and comparing the results with other biometric indices, the thesis aims to provide valuable insights into the effectiveness of fetal kidney length as a gestational age estimator and its potential clinical implications for prenatal care and decision-making. |