| CTRI Number |
CTRI/2021/05/033439 [Registered on: 07/05/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Baby in womb growth velocity and body proportions in assessment of growth. |
|
Scientific Title of Study
|
Fetal growth velocity and body proportions in assessment of growth. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K V Samskruthi |
| Designation |
Junior Resident |
| Affiliation |
Department of Obstetrics and Gynecology, KMC, Manipal. |
| Address |
Department of Obstetrics and Gynecology, KMC, Manipal. Department of Pediatrics, KMC, Manipal, Department of Data Science, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7382505411 |
| Fax |
|
| Email |
samskruthi1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akhila vasudeva |
| Designation |
Professor and unit chief, chief consultant of division of fetal medicine. |
| Affiliation |
Kasturba Hospital, Manipal institute of higher education |
| Address |
Department of Obstetrics and Gynecology, KMC, Manipal.
Department of FETAL MEDICINE,
KMC, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9591614792 |
| Fax |
|
| Email |
akhila.vasudeva@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
K V Samskruthi |
| Designation |
Junior Resident |
| Affiliation |
Department of Obstetrics and Gynecology, KMC, Manipal. |
| Address |
Department of Obstetrics and Gynecology, KMC, Manipal. Department of Pediatrics, KMC, Manipal, Department of Data Science, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7382505411 |
| Fax |
|
| Email |
samskruthi1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA HOSPITALS,KASTURBA MEDICAL COLLEGE, MADHAV NAGAR, MANIPAL 576104. |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
No sponsor |
| Type of Sponsor |
Other [No sponsor] |
|
|
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 |
| K V Samskruthi |
Kasturba hospital |
obstetrics and Gynecology department, kasturba hospital,Manipal.
Udupi
KARNATAKA |
7382505411
samskruthi1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy-delivering in KH Manipal-biometric parameters available in three gestational windows: 16-22 weeks(mostly 18 weeks), 26-30 weeks(mostly 28 weeks), 34-40 weeks (mostly 36 weeks), there should be minimum of 4 weeks between these USG. |
|
| ExclusionCriteria |
| Details |
Congenital malformations-Structural or genetic/chromosomal, multiple pregnancy, those delivering before growth scan between 26-30 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Newborn weight and GA at birth-SGA or AGA/LGA- preferably using intergrowth 21/WHO/IAP Standard nomograms. |
At delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse perinatal/neonatal outcome - one or more of the following criteria:
a. Intrapartum CTG abnormalities, requirement of intrauterine resuscitative measures for the same, requirement of operative delivery for the same, meconium stained liquor, Need for any resuscitation at birth, admission to the neonatal unit with reason.
b. Severe adverse perinatal outcome as stillbirth or term livebirth associated with neonatal death.
c. Neonatal anthropometry.
|
Perinatal period |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
07/05/2021 |
| 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="1"
Months="7"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Unselected obstetrics population recruited any time during their antenatal visits to KH Manipal, including the third trimister. USG biometric parameters are noted and traditional biometric centiles are noted down from Sonocare software used for all obstetric scans. Subsequent fetal biometric parameters noted down at 28th and 36th week, Conditional centiles are calculated from EFW at anomaly scan between 18-20th weeks, following which new conditional centile charts are created using the help of statistical algorithm available in the literature. Fetal growth velocity calculated based on the change in the conditional centiles. Fetal body proportions, mainly HC/AC ratio is noted down and plotted on HC/AC nomogram previously published to identify respective centiles, Z score and serial centiles in the same. After birth neonatal weight is plotted on the standard centile chart to assess the AGA/SGA pattern. Adverse neonatal outcomes related to FGR neonates- noted down, neonatal anthropometric parameters are noted down to help identify the true undernourished newborn from true IUGR. |