| CTRI Number |
CTRI/2024/04/064955 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Adverse perinatal outcomes in pregnancies with small for gestational age fetuses as compared to growth restricted fetuses and appropriately grown fetuses |
|
Scientific Title of Study
|
Adverse perinatal outcomes in pregnancies with small for gestational age fetuses as compared to growth restricted fetuses as per the Delphi consensus and appropriately grown fetuses |
| 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 K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Obstetrics
and Gynaecology AIIMS New Delhi 110029
New Delhi
South
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Obstetrics
and Gynaecology AIIMS New Delhi 110029
New Delhi
South
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yellareddy Srinidhi Reddy |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Obstetrics and Gynecology
Mother and child block
All India Institute of Medical sciences
Ansari Nagar 110029
New Delhi
South
DELHI
110029
India |
| Phone |
9676245548 |
| Fax |
|
| Email |
srinidhivreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences
Ansari Nagar
New Delhi – 110029 (India) |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution |
|
|
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 K Aparna Sharma |
AIIMS New Delhi |
Department of Obstetrics and Gynecology
Mother and child block
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
South
DELHI |
9711824415
kaparnasharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman with correct dates as per first trimester ultrasound
More than 28 weeks of gestation
Willing to be a part of the study and delivering at AIIMS New Delhi |
|
| ExclusionCriteria |
| Details |
Presence of a fetal chromosomal or structural abnormality
Multiple pregnancy
Refusing consent to be a part of the study
Not willing to follow up or deliver at AIIMS New Delhi |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Composite adverse perinatal outcome will be compared among the two groups as compared to the control group and that with respect to each other
The Composite adverse perinatal outcome will include
Perinatal demise stillbirth immediate neonatal demise or death before neonatal intensive
care unit NICU discharge
NICU admission
5 minute Apgar score of less than 7
Acute respiratory stress syndrome
Grade III to IV IVH and or PVL
Necrotising enterocolitis
Sepsis
Bronchopulmonary dysplasia
Anemia
Neonatal seizures |
At the time of recruitment
At the time of ultrasound for growth parameters
At the time of delivery
Post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of days of NICU stay
Number of days of hospital stay for baby
Proportion of FGR fetuses classified as small for date according to AIIMS new born charts
based on Hadlock, Intergrowth and WHO charts |
Post delivery |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
10/04/2024 |
| 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="2"
Months="0"
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
|
To determine adverse perinatal outcomes in pregnancies with small for gestational age fetuses as compared to growth restricted fetuses as per the Delphi consensus and appropriately grown fetuses. This is to understand the necessity of diagnosing as above as per the outcomes it states. |