| CTRI Number |
CTRI/2023/07/055578 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of fetal growth by WHO and Intergrowth-21 growth charts for Indian Population |
|
Scientific Title of Study
|
Comparison of fetal growth by WHO and Intergrowth-21 growth charts for Indian Population |
| 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 Sangeeta Gupta |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College Lok Nayak Hospital New Delhi |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604349 |
| Fax |
|
| Email |
drsangeetamamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Prasad |
| Designation |
Fellow Maternal Fetal Medicine |
| Affiliation |
Maulana Azad Medical College Lok Nayak Hospital New Delhi |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
07827177080 |
| Fax |
|
| Email |
prasaddrdivya6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Prasad |
| Designation |
Fellow Maternal Fetal Medicine |
| Affiliation |
Maulana Azad Medical College Lok Nayak Hospital New Delhi |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
07827177080 |
| Fax |
|
| Email |
prasaddrdivya6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology, Lok Nayak Hospital and Maulana Azad medical college New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Dr Sangeeta Gupta |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi |
| 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 Divya Prasad |
Maulana Azad Medical College and Lok Nayak Hospital |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI |
07827177080
prasaddrdivya6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant females attending antenatal OPD in LNH hospital Singleton pregnancy
Age more than 18 years
Body-mass index (BMI): ≥18 to 30kg/m2)
Gestational age more than 28 weeks |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females with
Singleton pregnancy
Age more than 18 years
Body-mass index (BMI)greater than 18 kg per m2 and less than 30kg per m2)
Gestational age more than 28 weeks (where dating by ultrasonography before 16 weeks is available)
Anomaly scan at 18-22 weeks with full morphological and biometric evaluation
No evidence in the present pregnancy of congenital disease or fetal anomaly
|
|
| ExclusionCriteria |
| Details |
History of recurrent miscarriages
Previous FGR
History of smoking cigarettes in the past six months
Used illicit drugs in the past year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of fetuses falling under various centiles
below ten centile
between ten & ninety centile and above ninety centile in fetal growth charts by WHO and INTERGROWTH 21 growth charts at gestational ages 30 to 32 weeks and 36 to 38 weeks respectively and compare the results in each group of centiles
Difference in fetal weight and birthweight by two charts and proportion with greater than 10 percentage difference
|
Pregnant women at gestational age between 30 to 32 weeks & 36 to 38 weeks respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Perinatal outcomes
5 min Apgar less than 7 Neonatal intensive care unit admissions & neonatal death in the three categories
below 10 centile
between 10 & 90 centile and above 90 centile |
After delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/08/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a prospective observational study comparing the growth centiles between WHO and INTERGROWTH 21 fetal growth charts and correlating it with INTERGROWTH 21 neonatal birthweight centiles. The primary outcome will be the percentage of fetuses falling under various centiles (below 10th centile, between 10th and 90th centile and above 90th centile) in fetal growth charts by WHO and INTERGROWTH 21 growth charts at gestational ages (30 to 32weeks and 36 to 38 weeks) respectively and compare the results in each group of centiles and the difference in fetal weight and birthweight by two charts and proportion with more than 10 percentage difference. The secondary outcome will be perinatal outcomes (5 min Apgar less than 7, neonatal intensive care unit admission and neonatal death) in the three categories i.e below 10th centile, between 10th and 90th centile and above 90th centile.
|