| CTRI Number |
CTRI/2024/05/066761 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining how the patterns of fetus heart rate before and during birth are related among the term and preterm deliveries and also establish fetal behavioral patterns based on before and during birth nonstress test variables in a diverse group of pregnant women at a tertiary care hospital. |
|
Scientific Title of Study
|
Correlation of Antepartum and Intrapartum Fetal Heart Rate Patterns in an unselected Obstetric Cohort at Tertiary Care Centre |
| 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 Vartika Maheshwari |
| Designation |
Post Graduate |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education |
| Address |
Department of OBG, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9302558361 |
| Fax |
|
| Email |
vartika.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhila Vasudeva |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education |
| Address |
Department of OBG, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9591614792 |
| Fax |
|
| Email |
akhila.vasudeva@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vartika Maheshwari |
| Designation |
Post Graduate |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education |
| Address |
Department of OBG, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9302558361 |
| Fax |
|
| Email |
vartika.kmcmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of OBG, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Vartika Maheshwari |
Kasturba Medical College, Manipal and Kasturba Hospital |
Department of OBG, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Udupi Karnataka 576104
Udupi
KARNATAKA |
9302558361
vartika.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O779||Labor and delivery complicated byfetal stress, unspecified, |
|
|
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 |
Adult pregnant women (from 26th week of gestation) who are already enrolled in the ongoing philips project )IEC 597/2021), who have visited department of OBG, KMC Manipal for their routine antenatal care and are admitted for labor at the Department of OBG, KMC Manipal |
|
| ExclusionCriteria |
| Details |
Pregnant women who are not enrolled in the Philips project (IEC 597/2021) even if they have visited Department of OBG, KMC Manipal for their routine antenatal care and are admitted for labor at the Department of OBG, KMC Manipal will not be recruited. Women admitted to HDU/ICU due to obstetric/non-obstetric problem. Women in need of emergency management. Critical non-pregnancy related health issues (Road traffic accidents etc.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome that the study intends is to correlate antepartum CTG and Intrapartum CTG among the term and preterm deliveries and establish fetal
behavioural patterns based on antenatal NST variables and then compared to intrapartum CTG patterns |
at least at 3 time points between 26 weeks till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="163"
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)
|
14/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Non-Stress test (NST)/cardiotocography (CTG) is a frequently used tool to determine the degree of fetal wellbeing. Good antenatal services backed up by vigilant antepartum and intrapartum monitoring for the progress of labour and fetal conditions are the mainstay in the management of pregnancies. A non-stress test is one of the biophysical techniques for assessing the fetal condition and is one of the mainstays in the management of most high-risk pregnancies. It can identify the fetus in jeopardy, in the compromised intrauterine environment and also the fetus that may not be able to tolerate the stress of labour. This enables an appropriate and timely intervention to achieve the most favourable neonatal outcome. Non Stress test helps us to understand both fetal heart rate and the uterine activity. If we establish a correlation between antenatal NST and intrapartum NST patterns, in future this may help us predict intrapartum fetal distress based on antenatal NST patterns. |