| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women in third trimester of pregnancy |
|
|
Intervention / Comparator Agent
|
|
|
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. |