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CTRI Number  CTRI/2024/01/061198 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 30/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Umbilical coiling index association with perinatal outcomes. 
Scientific Title of Study   Second trimester antenatal umbilical coiling index and doppler flow characteristics and their association with perinatal outcomes. 
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 Houmam Khan 
Designation  Junior resident  
Affiliation  D Y Pati Hospital and Research Center Kolhapur 
Address  Department of radiodiagnosis, D Y Patil Hospital and Research center, kadamwadi

Kolhapur
MAHARASHTRA
416001
India 
Phone  9967072140  
Fax    
Email  houmamisthebest@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Wadhwani 
Designation  Head of Department 
Affiliation  D Y Patil Hospital and Research Center Kolhapur 
Address  Department of radiodiagnosis, D Y Patil Hospital and Research Center, Kadamwadi

Kolhapur
MAHARASHTRA
416001
India 
Phone  9822028155  
Fax    
Email  drnitinwadhwani@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Houmam Khan 
Designation  Junior resident 
Affiliation  D Y Patil Hospital and Research Center Kolhapur 
Address  Department of radiodiagnosis, D Y Patil Hospital and Research center, kadamwadi

Kolhapur
MAHARASHTRA
416001
India 
Phone  9967072140  
Fax    
Email  houmamisthebest@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil Hospital and Research Center Kolhapur 
 
Primary Sponsor  
Name  Dr Houmam Khan 
Address  Department of radiodiagnosis, D Y Patil Hospital and Research center, kadamwadi. Kolhapur, Maharashtra 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Houmam Khan  D Y Patil Hospital And Research Center  Department of Radiodiagnosis
Kolhapur
MAHARASHTRA 		 9967072140

houmamisthebest@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee D Y Patil Medical College Kolhapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  singleton pregnancy between 13 to 28 weeks of gestation 
 
ExclusionCriteria 
Details  all high risk pregnancies like gestational diabetes mellitus, hypertension, Rh negative pregnancy, anomalous baby, single umbilical artery, delivery not performed at D Y Patil hospital kolhapur. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Find out umbilical coiling index and doppler parameters using ultrasound.  Second trimester. 
 
Secondary Outcome  
Outcome  TimePoints 
Find out if there is any association of umbilical coiling index & doppler parameters with adverse perinatal outcomes.  At delivery. 
 
Target Sample Size   Total Sample Size="127"
Sample Size from India="127" 
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)   15/01/2024 
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)   Not Applicable 
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  

 

PROJECT SUMMARY

The umbilical cord is the essential lifeline of fetus supplying nutrients,

oxygen and fluids necessary for life in utero. The trivascular conduit is well

protected by Whartons jelly, amniotic fluid and the helical pattern or coiling of

vessels.

Coiling of umbilical cord and its blood flow pattern has been the subject of

various anatomical and sonographic studies. These studies considered the

development, structure of umbilical cord, its blood flow pattern and assessed

utility of sonography to detect abnormal coiling and its blood flow pattern in

utero as a marker of foetal compromise.

This study will be done to determine whether abnormal umbilical cord coiling

patterns and its blood flow parameters measured sonographically between 13 to

28 weeks of gestation are associated with adverse perinatal outcomes.


NEED FOR STUDY

 

 

 Very few studies have assessed blood flow

characteristics utilizing Doppler ultrasound and its association with umbilical

cord coiling index and perinatal outcome. we hypothesized

that umbilical coiling index may be associated with abnormal cord blood flow

pattern and associated with various perinatal outcome.

 Hence if the coiling index and its Doppler

blood flow characteristics will be measured antenatally, it would act as a predictor

of adverse perinatal outcome.



RESEARCH QUESTION

 Can second trimester umbilical coiling index and its doppler flow characteristics be used to predict adverse perinatal outcome? 

 

AIM

To determine if any association is present between umbilical coiling index and doppler flow parameters in second trimester with adverse perinatal outcomes.

 

HYPOTHESIS

There is no association between umbilical coiling index and its doppler parameters measured in second trimester with adverse perinatal outcomes.

 

OBJECTIVES

To record umbilical coiling index and doppler flow parameters in second trimester.

To find any association between umbilical coiling index and its doppler flow parameters with perinatal outcomes.

 
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