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CTRI Number  CTRI/2024/06/068803 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 08/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Comparison of fetal weight estimation by clinical methods and ultrasonograpgy and its correlation with actual birth weight  
Scientific Title of Study   Comparative study of fetal weight estimation by clinical methods and ultrasound and its correlation with the 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 Lakkireddy Vaishnavi 
Designation  junior Resident 
Affiliation  Datta Meghe institute of higher education and research 
Address  Room no. F18, Jawaharlal Nehru Medical College, Sawangi (Meghe), Datta Meghe Institute of Higher education and research, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9553122251  
Fax    
Email  vaishnavi71098@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjusha Agrawal 
Designation  Professor  
Affiliation  Datta Meghe institute of higher education and research 
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  9823114705  
Fax    
Email  badnemanju@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lakkireddy Vaishnavi 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room no. F18,Shalinta Hostel, Datta Meghe Institute of Higher Education and Research, Sawangi (meghe), Wardha (442001)

Wardha
MAHARASHTRA
442001
India 
Phone  09553122251  
Fax    
Email  vaishnavi71098@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinoba Bhave Rural Hospital 
Self 
 
Primary Sponsor  
Name  Datta Meghe Institute of higher education and research 
Address  Datta Meghe Institute of higher education and research, Sawangi (Meghe), Wardha-442001 
Type of Sponsor  Research institution and hospital 
 
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 Lakkireddy Vaishnavi  Datta Meghe institute of higher education and research  In patient department, Department of Obstetrics and gynaecology, Acharya Vinoba Bhave rural hospital, Sawangi (meghe)
Wardha
MAHARASHTRA 
09553122251

vaishnavi71098@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Women in third trimester of pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Live fetus
2.Term pregnancy (Gestational age of 37-40 weeks)
3.Singleton pregnancy
4.Cephalic presentation
5.Known last menstrual period or ultrasound scan with confirmed expected
date of delivery
 
 
ExclusionCriteria 
Details  1.Multiple gestation
2.Non- cephalic presentation
3.Intrauterine fetal death
4.Presence of coexisting fibroids or adnexal masses
5.Already diagnosed liquor abnormalities
6.known fetal malformation
7.obesity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to compare the estimated fetal weight obtained from
clinical methods (Johnson’s formula, Insler’s formula, and McDonald’s measurement of

symphysio-fundal height) and ultrasound (using Hadlock’s formula) with the actual birth
weight of the neonate. This comparison will assess the accuracy and reliability of each
method in predicting fetal weight and provide insights into their clinical utility in a tertiary
care hospital setting in Central India. 
The study shall be conducted between 37 to 40 weeks of pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
accuracy of fetal weight estimation
correlation coefficients
factors influencing accuracy
clinical utility 
the study shall be conducted between 37 to 40 weeks of pregnancy 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   30/06/2024 
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="3"
Months="0"
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 - NO
Brief Summary  

Accurate estimation of fetal weight is of key importance in the Obstetrician’s  decision-making process in the antepartum and intrapartum management of pregnancy, along with gestational age and adequacy of maternal pelvis, to decide the management of labor and mode of delivery. Accurate estimates are essential, since abnormal fetal growth may be associated with perinatal and maternal risk.

Both low and excessive weights at delivery are associated with an increased risk of newborn complications during labour and puerperium.

Delivery of a macrosomic fetus is associated with prolonged labor and various delivery traumas, including shoulder dystocia, brachial plexus injuries and intrapartum asphyxia, as well as increased maternal risks such as birth canal injuries and postpartum hemorrhage.

World Health Organization (WHO) has recommended that newborns with birth weight less than 2500 grams may be considered to fall in low birth weight categories carrying relatively higher risk of perinatal and neonatal morbidity and mortality. About 80% of neonatal death and 50% of infant deaths occur among these group. These infants are more prone to develop recurrent infection, malnutrition, diabetes, hypertension and neuro developmental handicaps in their life time. Hence low birth weight is an important risk factor for adverse outcome in later life. Therefore estimation of fetal birth weight in intra uterine period happens to be of greater significance in early detection of intra uterine growth restriction and prevention of prematurity.

Management of diabetic pregnancy, vaginal birth after a previous caesarean section, and intrapartum management of foetuses presenting by the breech will be greatly influenced by estimated fetal weight.

Clinical methods of fetal weight estimation like Johnson’s formula and Insler’s formula can be used to predict expected fetal weight in low resource settings. Ultrasound is also used for estimation of expected fetal weight . But, it is not easily available in all places offering obstetric care, especially in low resource settings. Fetal weight estimation using ultrasound needs training, expertise and an expensive equipment. In such circumstances clinical methods of estimating fetal weight can aid in obstetric decision making.

 
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