| CTRI Number |
CTRI/2024/05/067993 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
USG Doppler in high-risk pregnant females to predict adverse outcomes in their babies. |
|
Scientific Title of Study
|
A Prospective observational study of fetal color Doppler and evaluation of Cerebroplacental Ratio as a predictor of adverse perinatal outcome in high risk pregnancy. |
| 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 Anjali Mishra |
| Designation |
1st year resident |
| Affiliation |
Radiology department, Sir Takhtasinhji General Hospital, Bhavnagar |
| Address |
Radiology Department, Room 9, Sir Takhtasinhji General Hospital, Government Medical College, Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9026277600 |
| Fax |
|
| Email |
anjalishranancy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehandi Vadasariya |
| Designation |
Head of the Department and Professor, Radiology Department |
| Affiliation |
Radiology department, Sir Takhtasinhji General Hospital, Bhavnagar |
| Address |
Department of Radiology, Sir Takhtasinhji General Hospital, Government Medical College, Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9026277600 |
| Fax |
|
| Email |
drmehandi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Mishra |
| Designation |
1st year resident |
| Affiliation |
Radiology department, Sir Takhtasinhji General Hospital, Bhavnagar |
| Address |
Department of Radiology, Sir Takhtasinhji General Hospital, Government Medical College, Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9026277600 |
| Fax |
|
| Email |
anjalishranancy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Takhtasinhji General Hospital, Government Medical College, Bhavnagar 364001, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Anjali Mishra |
Sir Takhtasinhji general hospital |
Department of Radiology, sonography Room no 9, Sir Takhtasinhji General Hospital, Bhavnagar.
Bhavnagar
GUJARAT |
9026277600
anjalishranancy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, (2) ICD-10 Condition: O093||Supervision of pregnancy with insufficient antenatal care, (3) ICD-10 Condition: O092||Supervision of pregnancy with other poor reproductive or obstetric history, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females with
Anaemia
DM (without any episode of hypoglycaemia)
HTN (without any episode of hypertensive urgency/ emergency)
Hypothyroidism (without any episode of hypothyroidism coma)
PIH and its spectrum.
Connective tissue disorders.
Rh Negative Pregnancy.
Females with Heart diseases |
|
| ExclusionCriteria |
| Details |
Pregnancies complicated by foetal anomaly or Aneuploidy.
Intra-uterine foetal demise.
Women undergoing caesarean section for indication other than intrapartum fetal compromise (IFC).
Diabetic females with episode/s of hypoglycaemia during pregnancy.
Hypertensive females with episodes of hypertensive urgency or emergency during pregnancy.
Females with hypothyroidism having any episode of hypothyroidism coma during pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To calculate Pulsatility Index, Resistive Index and Systolic/ Diastolic Ratio of Umbilical Artery, Middle Cerebral Artery and Uterine Arteries.
To calculate the Cerebroplacental Ratio. |
28 week to 41 week 6 days of Pregnancy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To predict Adverse perinatal outcome in fetus.
To decrease fetal mortality.
To aid in deciding further preventive steps in pregnancy |
28 week to 41 week 6 days of Pregnancy. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Antenatal Fetal Doppler is linked to various adverse conditions in fetus which may be a result of various risk factors in pregnant females. Deranged values of various parameters of the doppler can give us an idea about the fetuses at risk and preventive measures can be taken accordingly. |