| CTRI Number |
CTRI/2024/10/074633 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To help in the assessment of accurate gestational age in women with no dating scans
|
|
Scientific Title of Study
|
Evaluation of fetal kidney measurement as an adjunct to gestational age estimation in second and third |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RENUKANANDAN PATIL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BLDE SHRI BM PATIL MEDICAL COLLEGE AND RESEARCH CENTRE VIJAYAPURA |
| Address |
HOUSE NUMBER-1-12-23/22,OPPOSITE ESHWAR TEMPLE,DADDY COLONY,RAICHUR
SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL,VIJAYAPURA
Bijapur
KARNATAKA
584101
India |
| Phone |
9483880333 |
| Fax |
|
| Email |
renukanandan.patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sangamesh S Mathapathi |
| Designation |
Professor |
| Affiliation |
BLDE SHRI BM PATIL MEDICAL COLLEGE AND RESEARCH CENTRE VIJAYAPURA |
| Address |
Department of Obstetrics and Gynaecology ,Shri BM Patil Medical college, Vijayapura.
Department of Obstetrics and Gynaecology ,Shri BM Patil Medical college, Vijayapura.
Bijapur
KARNATAKA
586101
India |
| Phone |
9686266326 |
| Fax |
|
| Email |
Sangamesh.mathapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RENUKANANDAN PATIL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BLDE SHRI BM PATIL MEDICAL COLLEGE AND RESEARCH CENTRE VIJAYAPURA |
| Address |
Department of Obstetrics and Gynaecology, Shri B M Patil Medical college, Vijayapura
Department of Obstetrics and Gynaecology, Shri B M Patil Medical college, Vijayapura
Bijapur
KARNATAKA
586101
India |
| Phone |
9483880333 |
| Fax |
|
| Email |
renukanandan.patil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM PATIL MEDICAL COLLEG,BLDE(DU)VIJAYAPURA. |
|
|
Primary Sponsor
|
| Name |
SHRI BM PATIL MEDICAL COLLEGE AND RESEARCH CENTRE,VIJAYAPURA |
| Address |
SOLAPUR ROAD,BANGARAMMA SAJJAN CAMPUS,VIJAYAPURA,KARNATAKA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| RENUKANANDAN PATIL |
Shri BM PATIL MEDICAL COLLEGE,VIJAYAPURA |
Department of OBGY,Room no 2 shri BM Patil medical college,Vijayapura
Bijapur
KARNATAKA |
9483880333
renukanandan.patil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTUTIONAL ETHICS COMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
• Singleton pregnancies between gestational age of 20 to 40 weeks who have an appropriately done dating scan and with known LMP.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancies with obstetric and medical complications such as Hypertensive disorders of pregnancy, Gestational diabetes, Intrauterine growth restriction, Cardiac disease, epilepsy etc
2.Pregnancies with inherited renal an anomalies such as Polycystic kidney disease, Multi cystic dysplastic kidney
3.Pregnancies where fetus has known congenital renal anomalies including ectopic kidneys
4.Pregnancies with either unknown LMP or with no dating scan or both.
5.Pyelectasis with cut off value of 10 millimetres
|
|
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Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will help in assessing the ability of fetal kidney length measurement as a tool to estimate gestational age in patients with unknown LMP & with no dating scans.
It will help in estimating the gestational age in more precise way compared to existing biometric method.
|
four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will help in assessing the ability of fetal kidney length measurement as a tool to estimate gestational age in patients with unknown LMP & with no dating scans.
It will help in estimating the gestational age in more precise way compared to existing biometric method.
|
the study helps in assessment of gestational age in pregnant women accurately |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 26-04-2025 and end date provided 26-07-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims to estimate the gestational age accurately in second and third trimester of pregnancy by ultrasonographic measurement of fetal kidney length.This helps us to estimate the gestational age in women who donot have early pregnancy or dating scans. |