| 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
|
|
|
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
|
|
|
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. |