| CTRI Number |
CTRI/2024/05/067226 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction Of Neonatal Acidemia At Birth With Intrapartum Total Reperfusion Time On Fetal Cardiotocogram |
|
Scientific Title of Study
|
Prediction Of Neonatal Acidemia At Birth With Intrapartum Total Reperfusion Time On Fetal Cardiotocogram KAHERS DR Prabhakar Kore Hospital, Belagavi- A One Year 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 Korapala Vyshnavi |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
OBG Department,Jawaharlal Nehru Medical College,KLE University,Nehru Nagar,Belagavi,Karnataka, India- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9666234248 |
| Fax |
|
| Email |
vyshnavi7899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Romana Khursheed |
| Designation |
Proffesor, Department Of Obstetrics And Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Jawaharlal Nehru Medical College,KLE University,Belagavi,Karnataka, India-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9964892744 |
| Fax |
|
| Email |
romiarif@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Korapala Vyshnavi |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
OBG Department,Jawaharlal Nehru Medical College,KLE University,Nehru Nagar,Belagavi,Karnataka, India- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9666234248 |
| Fax |
|
| Email |
vyshnavi7899@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEH, Dr Prabhakar Kore Hospital,JNMC,Belagavi |
|
|
Primary Sponsor
|
| Name |
Korapala Vyshnavi |
| Address |
JNMC Campus,KLE University,Belagavi Karnataka,India-590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Korapala Vyshnavi |
Jawaharlal Nehru Medical College, KLEH, Belagavi |
G-1,Sagar Ward,Labour Room, KLE DR Prabhakar Kore Hospital, Nehru Nagar,BelagaviI Karnataka
Belgaum
KARNATAKA |
9666234248
vyshnavi7899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O68||Labor and delivery complicated byabnormality of fetal acid-base balance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Deceleration Pattern In Electronic Fetal Monitoring(2 Or More Decelerations In The Last 30 Minutes)
2. Term Gestation (37 To 42 Weeks)
3. Cephalic Presentation
4. No Fetal Anomalies |
|
| ExclusionCriteria |
| Details |
1. Uterine Rupture
2. Cord Prolapse
3. Shoulder Dystocia
4. Less Than 30 Minutes Trace Of Electronic Fetal Monitoring
5. Recurrent Loss Of Focus In Evaluation Of Electronic Fetal Monitoring |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Predictive Ability Of Total Intrapartum Fetal Reperfusion Time On Fetal Cardiotocogram As A Predictor Of Neonatal Acidemia At Birth |
42 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare The Predictive Ability Of Total Intrapartum Reperfusion Time With Total Deceleration Area |
42 Weeks |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
21/05/2024 |
| 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="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
|
NEED FOR THE STUDY: | There has been no fetal parameter that can classify fetal acidemia with a high discrimination ability till now.Recent publications have analysed the importance of deceleration physiology and use parameters such as the deceleration area,that reports accumulated hypoxemia[7,8]. Acidemia at the time of birth is a risk factor for neonatal morbidity including neurological injury Hypoxic ischemic encephalopathy Meconium aspiration syndrome Neonatal seizure Cerebral palsy Neonatal mortality It is essential to know about the fetal time available to recovering between deceleration and fetal ability to repeatedly activate the chemoreflex[.To measure total intrapartum fetal reperfusion time(fetal resilience) in CTG before delivery and assess their association with neonatal acidaemia among term infants. As per the recent research,measurement of total intrapartum reperfusion time(fetal resilience)is a promising parameter on CTG which is predictive of neonatal acidemia at birth than the type of deceleration |
DATA COLLECTION PROCEDURE: | The steps used for data collection are as follows: After obtaining the approval from ethical committee and a written informed consent, Subjects are recruited according to the inclusion and exclusion criteria A detailed history with physical examination is taken The 30min trace recording CTG is analysed Total reperfusion time is calculated Umbilical artery cord blood gas analysis at the time of delivery is obtained Neonates with cord blood PH <=7.2are considered as cases and those with PH > 7.2 are treated as Controls | |