| 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
|
|
|
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
|
|
|
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
- 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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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 - Proposals should be directed to [monika.kmcmpl2022@learner.manipal.edu].
- 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.
- 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. |