| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All healthy pregnant women who attended the Fetal Medicine for routine ultrasound , |
|
|
Intervention / Comparator Agent
|
|
|
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.
|