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CTRI Number  CTRI/2024/09/074284 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Novel study in predicting FGR  
Scientific Title of Study   Significance of Pulmonary Vein Pulsatility Index (PVPI) in detecting Fetal growth restriction(FGR) and it’s correlation to umbilical cord pH- a case control study 
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 Aditi Asthana 
Designation  PG resident 
Affiliation  Jawaharlal Nehru Medical college KLE University , Belagavi Karnataka  
Address  Department of Obstetrics and Gynaecology , Jawaharlal Nehru Medical college KLE University , Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  09956064505  
Fax    
Email  aditi.asthana16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MB Belllad 
Designation  PROFESSOR 
Affiliation  Jawaharlal Nehru Medical college KLE University , Belagavi Karnataka  
Address  Department of Obstetrics and Gynaecology , Jawaharlal Nehru Medical college KLE University , Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9448124893  
Fax    
Email  mbbellad@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MB Belllad 
Designation  PROFESSOR 
Affiliation  Jawaharlal Nehru Medical college KLE University , Belagavi Karnataka  
Address  Department of Obstetrics and Gynaecology , Jawaharlal Nehru Medical college KLE University , Belagavi Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9448124893  
Fax    
Email  mbbellad@hotmail.com  
 
Source of Monetary or Material Support  
KAHERS Dr Prabhakar Kore Hospital and Medical Research Centre Belagavi- 590010 Karnataka India  
 
Primary Sponsor  
Name  Dr Aditi Asthana 
Address  c-1 , 2nd floor, Om Nilaya Apartment , shiv basav nagar, belagavi 890010, karnataka , india 
Type of Sponsor  Other [Dr Aditi Asthana] 
 
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 Aditi Asthana  Dr Prabhakar Kore Hospital and Medical Research Centre , Belagavi   Department of obstetrics and gynaecology Dr Prabhakar Kore Hospital and Medical Research Centre , Belagavi , Karnataka
Belgaum
KARNATAKA 
09956064505

aditi.asthana16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: P018||Newborn affected by other maternalcomplications of pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. All pregnant women with more than 28 weeks period of gestation
2. Singleton pregnancies  
 
ExclusionCriteria 
Details  Those with known structural and chromosomal abnormalities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the role of Pulmonary Vein Pulsatility Index (PVPI) in Fetal Growth Restriction (FGR).  42 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the corelation between Pulmonary Vein Pulsatility Index (PVPI) and Umbilical cord pH in Fetal Growth Restriction (FGR) newborns  42 weeks 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   15/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  
Fetal Growth Restriction is a failure of the fetus to reach its expected biological growth, based on its genetically predetermined potential. Whenever effective fetal weight is less than, 10th percentile or 2 standard deviation of population specific growth curve, it is considered small for gestational age(SGA). The FGR is a pathological state, based on additional criteria of EBW <3dr percentile, poor somatic growth and compensated umbilical/cerebral blood flow and is associated with poor somatic growth with concomitant changes in placental and cerebral blood flow and/or biochemical markers along with EBW<3rd percentile a common condition affecting about 10-15% of general maternity population. 
It is associated with increased risk of Intrauterine Fetal Death (IUFD), intracranial hemorrhage, respiratory distress syndrome, neonatal lung disease, necrotizing enterocolitis, chronic cardiovascular disorders and renal disorders.
FGR fetuses are at increased risk of perinatal morbidity and mortality.
Fetal Doppler studies is an expanding field, and functional studies are now an essential part of the routine examination. Fetal venous Doppler studies represent valuable diagnostic techniques that can influence the management of FGR fetus as it helps in identification of the fetus at risk for perinatal complications and help in prediction of neonatal complications.
Alterations of venous flow volume forms precede fetal heart rate deaccelerations offering warning sign to act before a fetal life-threatening situation occurs. Doppler assessment of the venous system is important in the surveillance of compromised growth restricted fetus, as it can improve perinatal mortality and morbidity by optimizing time of delivery?
The Doppler indices measured from the ductus venosus, umbilical arteries ,Cerebro-placental and umbilico- cerebral Doppler ratio have been shown to correlate with the wellbeing of fetal growth restricted fetuses, which includes umbilical artery pH.
Umbilical artery pH (UApH) is essential for assessing adverse pregnancy outcomes since it predicts the risk that neurodevelopmental problems will manifest in childhood. However evidence during past two decades has shown that Small for Gestational Age (SGA), as defined by a normal UA pulsatility index, contains a large proportion of foetuses with worse perinatal outcomes than normally grown foetuses and thus UA Doppler cannot be a standalone criterion to differentiate FGR from SGA. 
Ductus venous is the strongest single Doppler parameter to predict the short term risk of fetal death in early onset FGR however DV waveforms become abnormal only in advanced stages of fetal compromise. This study will therefore help in assessing fi PVPI can be used as a predictor of adverse perinatal outcome before Ductus Venosus (DV) changes appear.
This study therefore aims to observe the importance of Pulmonary Vein Pulsatility Index (PVPI) in predicting adverse perinatal and postnatal outcomes in FGR in clinical practice and
to investigate the relationship between Pulmonary Vein Pulsatility Index (PVPI) and umbilical cord pH in FGR neonates especially in India as there is insufficient literature on the subject and a gap in the knowledge on the subject.
Since umbilical artery blood is difficult to access in neonates, it is rather a more practical approach to take umbilical cord blood pH as a marker and not specifically umbilical artery pH as ti may lead to inefficient results.
STUDY PROTOCOL- All the willing pregnant women who are more than 28 weeks coming to KAHER’S Dr. Prabhakar Kore Hospital delivering in labour rooms or undergoing Caesarean sections will be included in the study.
After obtaining approval from the ethical committee, permission will be taken for a waiver of consent.
The patients who satisfy the inclusion criteria and do not fall under the exclusion criteria will be recruited in the study.
 
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