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CTRI Number  CTRI/2024/02/062994 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal 
Study Design  Other 
Public Title of Study   Clinical estimation of fetal weight in pregnancy 
Scientific Title of Study   Estimation of fetal weight in term singleton pregnancy by various clinical methods and its correlation with actual birth weight 
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 Monika Dinkar 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  Junior resident, Department of Obstetrics and Gynaecology,Kasturba Medical college and hospital, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7631346265  
Fax    
Email  monika.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shripad Hebbar 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Head of department of obstetrics and gynaecology, Kasturba Medical college,MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9611786463  
Fax    
Email  shripad.hebbar@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shripad Hebbar 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Head of department of obstetrics and gynaecology, Kasturba Medical college,MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9611786463  
Fax    
Email  shripad.hebbar@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital , Manipal 
 
Primary Sponsor  
Name  Dr Monika Dinkar 
Address  1121, New International Hostel , block A , MAHE, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monika Dinkar  Kasturba Hospital  Obstetrics and Gynaecology department , women and child block
Udupi
KARNATAKA 
7631346265

monika.kmcmpl2022@learner.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 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Term singleton pregnant females 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Singleton pregnancy
2. Cephalic presentation
3. Live foetus
4. Gestational age 37-40 weeks
5. Agrees to follow-up weekly (at 36 weeks and onwards) 
 
ExclusionCriteria 
Details 
1. Multiple gestation
2. Anomalous foetus
3. Non- cephalic presentation
4. Intrauterine foetal death
5. Presence of coexisting fibroids, ovarian cysts
6. Already diagnosed liquor abnormalities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To compare the difference in mean percentage error in estimation of fetal weight against actual weight, between clinical and USG methods.

2. To assess the accuracy and degree of correlation of estimated fetal weight by clinical methods with actual birth weight in term pregnancy. 
At the time of recruitment  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable  
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "385"
Final Enrollment numbers achieved (India)="385" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/01/2025 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [monika.kmcmpl2022@learner.manipal.edu].

  6. For how long will this data be available start date provided 09-12-2025 and end date provided 09-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  

This study was undertaken to evaluate the accuracy of various clinical methods for fetal weight estimation in comparison with the actual birth weight and secondarily compare the accuracy with ultrasound-based Hadlock’s formula, given the critical role of fetal weight in obstetric decision-making and the limited availability of ultrasound in resource-constrained settings. A prospective observational study was conducted on 385 term singleton pregnancies (37–40 weeks) with cephalic presentation and no complicating fetal or maternal conditions. Estimated fetal weights were calculated using Johnson’s, Dare’s, and Kongnyuy-Mbu’s clinical formulas, as well as Hadlock’s ultrasound method, and compared with actual birth weight post-delivery.

The actual mean birth weight was 3117.02 ± 323.89 g. Hadlock’s method demonstrated the highest accuracy (mean absolute percentage error [APE]: 5.60 ± 4.97%) and the strongest correlation with actual weight (ICC = 0.72). Among clinical methods, Kongnyuy-Mbu’s formula performed best (APE: 5.89 ± 5.41%, ICC = 0.77), followed by Dare’s and Johnson’s. All methods showed significant correlation with actual birth weight (p < 0.001). Within ±10% of actual birth weight, Kongnyuy-Mbu’s (83.4%) and Hadlock’s (83.1%) methods were most accurate. Bland-Altman analysis confirmed good agreement across all methods.

The findings affirm that while ultrasound remains the gold standard, clinical methods—especially Kongnyuy-Mbu’s—can serve as reliable and practical alternatives in settings lacking ultrasound access, offering substantial clinical utility for fetal weight estimation in routine antenatal care.

 
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