| CTRI Number |
CTRI/2023/08/057083 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A correlative study between ultrasonographic foetal weight versus clinical estimation of fetal weight by Inslers formula to the actual birth weight in patients with pre eclampsia
|
|
Scientific Title of Study
|
Correlation of ultrasonographic estimation of fetal weight with clinical estimation of fetal weight by inslers formula to the actual birth weight in patients with pre-eclampsia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHREYA BHAT |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS
SOLAPUR ROAD BIJAPUR
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS SOLAPUR ROAD BIJAPUR
Bijapur
KARNATAKA
586103
India |
| Phone |
9686100638 |
| Fax |
|
| Email |
shreyakhandige@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHOBHA SHIRAGUR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS SOLAPUR ROAD BIJAPUR
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS SOLAPUR ROAD BIJAPUR
Bijapur
KARNATAKA
586103
India |
| Phone |
9663330846 |
| Fax |
|
| Email |
shobha.shiragur@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SHREYA BHAT |
| Designation |
JUNIOR RESIDENT (POST GRADUATE) |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS SOLAPUR ROAD BIJAPUR
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS SOLAPUR ROAD BIJAPUR
Bijapur
KARNATAKA
586103
India |
| Phone |
9686100638 |
| Fax |
|
| Email |
shreyakhandige@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College hospital and research center bangaramma sajjan campus solapur road department of OBG |
|
|
Primary Sponsor
|
| Name |
SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
OBG OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS SOLAPUR ROAD DEPARTMENT OF OBG |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHREYA BHAT |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA CAMPUS SOLAPUR ROAD
Bijapur
KARNATAKA |
9686100638
shreyakhandige@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE (DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER VIJAYAPURAINSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CORRELATION OF ULTRASONOGRAPHIC ESTIMATION OF FETAL WEIGHT WITH CLINICAL ESTIMATION OF FETAL WEIGJHT BY INSLERS FORMULA TO THE ACTUAL BIRTH WEIGHT IN PATIENTS WITH PRE ECLAMPSIA-PROSPECTIVE COMPARATIVE STUDY |
IN A PATIENT WITH PRE ECLAMSIA
WITH GETSTATIONAL AGE OF MORE THAN 28 WEEKS TILL TERM THE ULTRASONOGRAPHIC FETAL WEIGHT ESTIMATED WITHIN 48HOURS OF DELIVERY VERSUS CLINICAL ESTIMATION OF FETAL WEIGHT BY INSELRS FORMULA IN ANTENATAL PERIOD TO THE ACTUAL BIRTH WEIGHT IMMEDIATE AFTER BIRTH OF THE BABY. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 PREGNANT LADY OF GESTATIONAL AGE MORE THEN 28 WEEKS TO TERM WITH PRE ECLAMPSIA
2 SINGLETON PREGNANCY WITH CEPHALIC PRESENTATION |
|
| ExclusionCriteria |
| Details |
1 KNOWN FETAL MALFORMATION
2 MATERNAL OBESITY
3 ANY ADNEXAL MASS
4 MUULTIPLE GESTATION
5 FIBROID WITH PREGNANCY
6 PRESENTATION OTHER THAN CEPHALIC |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECTIVENESS OF ULTRASONOGRAPHIC FETAL WEIGHT ESTIMATION TO THAT OF CLINICAL ASSESMENT OF FETAL WEIGHT BY INSLERS FORMULA AND ITS ACCURACY COMPARED TO THE ACTUAL BIRTH WEIGHT AFTER DELIVERY OF THE BABY IN PATIENTS WITH PRE ECLAMPSIA |
TO COMPARE THE EFFECTIVENESS OF ULTRASONOGRAPHIC FETAL WEIGHT ESTIMATION TO THAT OF CLINICAL ASSESMENT OF FETAL WEIGHT BY INSLERS FORMULA AND ITS ACCURACY COMPARED TO THE ACTUAL BIRTH WEIGHT AFTER DELIVERY OF THE BABY IN PATIENTS WITH PRE ECLAMPSIA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 TO ASSES THE MODE OF DELIVERY CESAREAN SECTION OR INDUCED NORMAL LABOUR
2 TO ASSES MATERNAL COMPLICATIONS
3 TO ASSES NEONTAL OUTCOME BASED ON THE TREATMENT GIVEN TO THE MOTHER AS A RESULT OF WEIGHT ESTIMATION BEFORE DELIVERY |
24 HOURS |
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
10/09/2023 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).
- For how long will this data be available start date provided 05-09-2022 and end date provided 05-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
THE FOLLOWING STUDY WILL INCLUDE PREGNANT WOMEN WITH PRE ECLAMSIA WITH GESTATIONAL AGE BETWEEN 28 WEEKS TO 40 WEEKS VISITING THE DEPARTEMNT OF OBGYN SHRI B M PATIL MEDICAL COLLEHE HOSPITAL AND RESEARCH CENTER AND VIJAYAPURA WHO FULFIL THE INCLUSION CRITERIA THE STUDY IS DONE ON THE SAME INDIVIDUAL AND EFFECTIVE FETAL WEIGHT OF BABY IS MEASURED BY THREE TECHNIQUES AT THREE DIFFERENT TIME PERIODS INITIALLY ULTRASONOGRAPHIC FETAL WEIGHT IS ESTIMATED WHICH SHOULD BE DONE WITHIN 448 HOURS OF DELIVERY THIS IS INTURN COMPARED TO CLINICAL ESTIMATION OF FETAL WEIGHT BY INSELRS FORMULA FEW HOURS PRIOR DELIVERY BOTH OF THE ABOVE PARAMETERS ARE COMPARED TO ACTUAL BIRTH WEIGHT IMMEDIATELY AFTER DELIVERY BY DOING THIS THE DOCTOR CAN ASSES THE MODE OF DELIVERY PRIOR TO BIRTH OF BABY AND ALSO ESTIMATE THE FETAL OUTCOME BY KNOWING THE FETAL WEIGHT WELL IN ADVANCE IN PRE ECLAMPTIC PATIENTS FETAL GROWTH RESTRICTIONS AND OLIGOHYDROMNIOS ARE NOTED COMPLICATIONS HENCE THE FETAL WEIGHT MIGHT BE UNDERESTIMATED CLINICALLY OR ULTYRASONOGRAPHICALLY TO BRIDGE THIS GAP THIS STUDY IS UNDERTAKEN AND TO ASSES THE ACURACY OF EACH OF THE METHODS IN PRE ECLAMPTIC PATIENTS |