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CTRI Number  CTRI/2015/01/005401 [Registered on: 14/01/2015] Trial Registered Retrospectively
Last Modified On: 07/01/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Indian growth charts for the fetus  
Scientific Title of Study   Fetal biometry reference charts for North Indian Population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chanchal Singh 
Designation  Consultant 
Affiliation  Apollo Centre for Fetal Medicine 
Address  Apollo Centre for Fetal Medicine Indraprastha Apollo Hospital
D701, Kaveri Apartments, Alaknanda
South
DELHI
110076
India 
Phone  9899092076  
Fax    
Email  chanchalsngh@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Chanchal Singh 
Designation  Consultant 
Affiliation  Apollo Centre for Fetal Medicine 
Address  Apollo Centre for Fetal Medicine Indraprastha Apollo Hospital
D701, Kaveri Apartments, Alaknanda

DELHI
110076
India 
Phone  9899092076  
Fax    
Email  chanchalsngh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Chanchal Singh 
Designation  Consultant 
Affiliation  Apollo Centre for Fetal Medicine 
Address  Apollo Centre for Fetal Medicine Indraprastha Apollo Hospital
D701, Kaveri Apartments, Alaknanda

DELHI
110076
India 
Phone  9899092076  
Fax    
Email  chanchalsngh@yahoo.com  
 
Source of Monetary or Material Support  
None  
 
Primary Sponsor  
Name  Apollo Centre for Fetal Medicine 
Address  Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi 110076 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
None    
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chanchal  Apollo Centre for Fetal Medicine  Department of Obstetrics and Gynaecology, Gate number 7, Ground Floor,Indraprastha Apollo Hopsital
New Delhi
DELHI 
9899092076

chanchalsngh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee on Clinical Trials, Indraprastha Apollo Hospitals, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All healthy pregnant women who attended the Fetal Medicine for routine ultrasound ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Low risk women with singleton pregnancy
2. Confirmed gestation
3. Gestation between 16 weeks + 0 days to 40 weeks + 0 days
 
 
ExclusionCriteria 
Details  1. Multiple pregnancy
2. Unsure gestation
3. Pre-existing medical disorders
4. Obstetric complications like gestational hypertension, gestational diabetes, preterm delivery
5. Fetal abnormality
6. Abnormal result of invasive testing  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fetal Biometry reference charts for North Indian population   31st Decemeber, 2013 
 
Secondary Outcome  
Outcome  TimePoints 
Nomograms for fetal growth parameters for North Indian low risk women   6 years  
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2007 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="6"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Fetal biometry is an integral part of obstetric management starting form accurate estimation of the gestational age in the first trimester to assessment as well as monitoring of fetal growth later in pregnancy. It is long recognised that these measurements are specific to different populations and the best charts for a particular ethnicity should be based on ‘nomograms’ established for that population. This study was undertaken to establish reference ranges for fetal biometry for healthy Indian women. This retrospective observation study includes all low risk pregnant women who attended the Fetal Medicine clinic from January 2007 to January 2013 for routine obstetric ultrasounds and went on to deliver a healthy newborn at or after 37 weeks. The number of ultrasound examinations were limited to three per fetus. All women signed an informed consent for the study. Care was taken during data collection to strictly maintain the confidentiality of all participants . The 5th, 10th, 50th, 90th and 95th centiles for each growth parameter (biparietal diameter, head circumference, abdominal circumference and femur length) was calculated for each gestational week from 16 to 40 weeks and plotted to make nomograms.

 

 
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