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CTRI Number  CTRI/2024/10/075290 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of role of various characteristics of babys heart beat from monitor in pregnant women during labour in prediction of low oxygen levels in babys blood.  
Scientific Title of Study   Role of various Cardiotocography characteristics in prediction of fetal acidemia at birth. 
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 SAMEERA CHEGU 
Designation  JUNIOR RESIDENT 
Affiliation  Kasturba medical college,Manipal 
Address  Department of Obstetrics and Gynecology, Kasturba Medical college, Manipal, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9441385141  
Fax    
Email  sammy_ramesh@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR SUJATHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Kasturba medical college,Manipal 
Address  Department of Obstetrics and Gynecology, Kasturba Medical college, Manipal, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8660778169  
Fax    
Email  bs.sujata@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DR SHRIPAD HEBBAR 
Designation  PROFESSOR AND HEAD OF DEPARTMENT 
Affiliation  Kasturba medical college, Manipal 
Address  Department of Obstetrics and Gynecology, Kasturba Medical college, Manipal, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9611786463  
Fax    
Email  shripad.hebbar@manipal.edu  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynecology, Kasturba Medical college, Manipal, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India 
 
Primary Sponsor  
Name  Department of Obstetrics and Gynecology, 
Address  Kasturba Medical college, Manipal, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India 
Type of Sponsor  Private medical college 
 
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 Sameera Chegu  Kasturba hospital,Manipal  Department of Obstetrics and gynecology, Kasturba hospital, Manipal
Udupi
KARNATAKA 		 9441385141

sammy_ramesh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and kasturba hospotal institutional ethics committee-Student research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  All consecutive women labouring at ≥ 37 weeks to 41 weeks with a singleton gestation who are admitted in labour ward at department of obstetrics and gynecology, kasturba hospital , with suspicious or pathological CTG pattern (according to FIGO ) atleast 2 hours prior to delivery. 
 
ExclusionCriteria 
Details  Patients with gestational age less than 37 week
and greater than 41weeks
Patients with normal Cardiotocographic(CTG) patterns
Pregnancies complicated by congenital anomalies
Patients with insufficient CTG recordings less than 10 mins prior to delivery.
Maternal infection and fever
Elective C section
Still birth
Patient not willing to consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We intend to study the following parameters of cardiotocography on the study group that is Baseline FHR, Beat to beat variability,Total acceleration area,Total deceleration area,Minimum acceleration depth, Minimum deceleration depth, Maximum deceleration depth, Maximum acceleration depth and correlate to incidence of fetal acidemia.
To derive the prediction model using various CTG characteristics to detect fetal acidemia at birth.
 		 cross sectional study
 
 
Secondary Outcome  
Outcome  TimePoints 
Neonatal outcomes & morbidity like APGAR- 1’, 5’scores, NICU stays in view of morbidities like neonatal encephalopathy, neonatal sepsis, necrotizing enterocolitis.  0, 1 day , 3 days, 7 days
 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   25/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
  • It is a prospective cross sectional study.
  • The objectives of the study are
  1. To assess the relationship between various cardiotocography (CTG) characteristics with cord blood pH level at birth in fetus with abnormal CTG patterns according to FIGO guidelines.
  2. To derive the prediction model using various CTG characteristics to detect fetal acidemia at birth.
  3. To assess the correlation between various CTG characteristics with neonatal outcomes.
  • Participants will be recruited from in patients presenting to labour ward. A few questions will be asked to collect the socio demographic details and the obstetric details according to proforma. Photographs of the 10 minute suspicious or pathological CTG trace according to FIGO guidelines from last 2 hours CTG trace prior to delivery of the patient in labour ward will be taken and various CTG features like accelerations,  acceleration area, decelerations, deceleration area, acceleration to deceleration area ratio, baseline fetal heart rate, variability will be interpretated using strict and unambiguous definitions from FIGO criteria and are used to categorise the CTG recordings into one of the categories normal, suspicious or pathological. The patients having suspicious or pathological  CTG trace are recruited. Post delivery of the baby and handing over the baby to pediatrician for post birth care after clamping and cutting the umbilical cord between the two hemostatic clamps, a third clamp is placed on the maternal side of placenta to stabilise the segment of the umbilical cord . Cord arterial blood will be collected from the segment of the umbilical cord for arterial blood gas analysis (ABG)  and processed within 10 minutes of collection and correlation of the cord blood pH at birth is made.
  •  It is standard practice for collection of umbilical cord blood for cord blood pH and does not have any anticipated risks to mother and the baby. The neonates of such mothers will be monitored for requirement of  NICU stay. Neonatal outcome will be monitored for neonatal morbidity at discharge or death. A correlation will be made between CTG characteristics and outcome of the neonates. data will be analysed according to statistical methods mentioned and association between abnormal CTG according to FIGO guidelines and strength of association between between CTG characteristics and fetal acidemia determined.

 
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