| CTRI Number |
CTRI/2015/10/006261 [Registered on: 15/10/2015] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of foot length and hind brain measurements by ultrasonography for estimating age of the baby in the womb |
|
Scientific Title of Study
|
Gestational age estimation using fetal foot length and transcerebellar diameter - A prospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tahmina S |
| Designation |
Assistant Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Obstetrics and Gynaecology,Pondicherry Institute of Medical Sciences,
Kalathumettupathai, Ganapathichettikulam, Village Number 20, Kalapet
Pondicherry
PONDICHERRY
605 014
India |
| Phone |
8870730885 |
| Fax |
|
| Email |
dr.tahmina.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tahmina S |
| Designation |
Assistant Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Obstetrics and Gynaecology,Pondicherry Institute of Medical Sciences,
Kalathumettupathai, Ganapathichettikulam, Village Number 20, Kalapet
Pondicherry
PONDICHERRY
605 014
India |
| Phone |
8870730885 |
| Fax |
|
| Email |
dr.tahmina.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tahmina S |
| Designation |
Assistant Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Obstetrics and Gynaecology,Pondicherry Institute of Medical Sciences,
Kalathumettupathai, Ganapathichettikulam, Village Number 20, Kalapet
Pondicherry
PONDICHERRY
605 014
India |
| Phone |
8870730885 |
| Fax |
|
| Email |
dr.tahmina.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Tahmina S |
| Address |
Department of Obstetrics and Gynaecology,Pondicherry Institute of Medical Sciences,
Kalathumettupathai, Ganapathichettikulam, Village Number 20,
Kalapet, Puducherry - 605 014, INDIA |
| 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 |
| Tahmina S |
Pondicherry Institute of Medical Sciences |
Department of Obstetrics & Gynecology
Pondicherry
PONDICHERRY |
8870730885
dr.tahmina.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gestational age calculated from Crown rump length (CRL) |
CRL calculated between 8 to 12weeks +6 days |
| Intervention |
Ultrasonographic measurement of Transcerebellar diameter and fetal foot length |
4 weekly measurements |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
• Singleton pregnancy
• Gestational age at entry is between 8 + 0 to 12 + 6 weeks based on LMP, confirmed by ultrasonography
• Not on any long-term medications
• Non smokers/ no illicit drug use
|
|
| ExclusionCriteria |
| Details |
Intrauterine fetal demise or major congenital anomaly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Calculation of relationship of TCD and FFL with gestational age |
Throughout pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of fetal growth standards using TCD and FFL |
Throughout pregnancy |
|
|
Target Sample Size
|
Total Sample Size="161"
Sample Size from India="161"
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)
|
02/11/2015 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study will be undertaken
in the Dept. of Obstetrics & Gynaecology at Pondicherry Institute of Medical
Sciences, Pondicherry. Pregnant women satisfying the inclusion
criteria, after obtaining a written informed consent, will be enrolled into the
study between 8 + 0 weeks and 12 + 6 weeks. Fetuses will be scanned in the first trimester for the estimation of gestational age by measurement of crown-rump length (CRL), and then subsequently at monthly intervals for fetal biometry from 18 weeks onwards till 40 weeks. All scans will be performed by the
primary investigator or co-investigator. The following ultrasound measurements will
be obtained at all visits: Biparietal diameter (BPD), Head circumference (HC), Abdominal
circumference (AC), Femur length (FL), Transcerebellar diameter (TCD) and Fetal Foot length (FFL). Patients will be followed up until delivery and birthweight will be noted. Data will be entered in Microsoft Excel spread sheet and analysed using SPSS software. Linear regression models for estimation of gestational age will be
derived from the biometric indices, fetal foot length and transcerebellar
diameter. Correlation tests will be applied to measure the correlation between FFL, TCD and gestational age;
and to compare them with the other biometric parameters.
|