FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/08/015286 [Registered on: 13/08/2018] Trial Registered Retrospectively
Last Modified On: 02/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Comparitive study 
Study Design  Other 
Public Title of Study   Comparison of outcome of normal pregnancy and pregnancy with complications based on cerebroplacental ratio detected by ultrasound scan 
Scientific Title of Study   Comparison of outcome of Low-risk and High-risk pregnancies based on fetal cerebroplacental ratio assessed by Doppler studies 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shemini Saleem 
Designation  Resident Obstetrics and Gynecology 
Affiliation  Kerala Institute of Medical Science 
Address  Kerala Institute of Medical Science PB No. 1 Anayara Trivandrum

Thiruvananthapuram
KERALA
695029
India 
Phone  9846634057  
Fax    
Email  drshemini@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vidyalekshmy R 
Designation  Coordinator High risk OBG and Consultant Perinatology 
Affiliation  Kerala Institute of Medical Science 
Address  Kerala Institute of Medical Science PB No. 1 Anayara Trivandrum

Thiruvananthapuram
KERALA
695029
India 
Phone  9495959496  
Fax    
Email  drvidyalekshmy@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Shemini Saleem 
Designation  Resident Obstetrics and Gynecology 
Affiliation  Kerala Institute of Medical Science 
Address  Kerala Institute of Medical Science PB No. 1 Anayara Trivandrum

Thiruvananthapuram
KERALA
695029
India 
Phone  9846634057  
Fax    
Email  drshemini@gmail.com  
 
Source of Monetary or Material Support  
Kerala Institute of Medical Science 
 
Primary Sponsor  
Name  Kerala Institute of Medical Science 
Address  PB No.1 Anayara P.O Trivandrum 
Type of Sponsor  Research institution and hospital 
 
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 
Shemini Saleem  Kerala Institute of Medical Science  Department of Obstetrics and Gynecolog Kerala Institute of Medical Science PB No. 1 Anayara P.O Trivandrum
Thiruvananthapuram
KERALA 
9846634057

drshemini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee Kerala Institute of Medical Science Trivandrum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant women 28 to 36 weeks,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Low-risk Pregnancy

a.Singleton pregnancy
b.Gestational age of patient should be between 30 and 38 weeks

2.High-risk Pregnancy

a.Singleton pregnancy
b.Gestational age of patient should be between 30 and 38 weeks
c.At least one of the following risk factor was present in study group pregnant women.
i.Gestational hypertension
ii.Essential hypertension
iii.Prior neonatal death
iv.Diabetes mellitus
v.Malnutrition
vi.Anemia 
 
ExclusionCriteria 
Details  1.Multiple Pregnancy
2.Congenital anomalies in fetus
3.Not willing to participate
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Perinatal outcome - Admission in NICU
 
Up to two week post delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Obstetrical outcome - Mode of Delivery
 
Till Delivery 
 
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)   12/04/2018 
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)  Open to Recruitment 
Publication Details   Not Yet completed 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

FGR is normally used to refer to small fetuses with higher risk for fetal inutero deterioration, stillbirth and overall poorer perinatal outcome as compared with normally grown fetuses. They are associated with Doppler signs suggesting hemodynamic redistribution as a reflection of fetal adaptation to under nutrition /hypoxia, histological and biochemical signs of placental disease and a higher risk of preeclampsia. The term SGA has been used to differentiate a subgroup of small fetuses that do not present the changes described above. While the concepts of FGR and SGA may be clear, distinction of ‘True FGR’ in clinical practice can be challenging.

 

                    Population based series show that prenatal identification of SGA babies’ results in a reduction of adverse perinatal outcome and stillbirth. However, most SGA babies remain unnoticed until birth, even when routine third trimester ultrasound is performed. In late SGA fetuses, abnormal CPR is present before delivery in 20-25% of the cases. We propose that low fetal CPR is associated with adverse perinatal outcome. This study aims to evaluate the Cerebro Placental Ratio, which is the ratio of Pulsatality Index of fetal middle cerebral and Umbilical Artery, in normal and high-risk pregnancies during 28 – 36 weeks of gestation and compare the fetal and neonatal outcome.

 
Close