| CTRI Number |
CTRI/2024/04/065158 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare a new fetal heart rate monitoring machine with routinely used machine during delivery of baby. |
|
Scientific Title of Study
|
Comparison of a new novel fetal heart rate monitoring device to standard cardiotocography in detecting fetal heart rate during intrapartum period. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Bhakat |
| Designation |
DM Postgraduate resident |
| Affiliation |
Madras Medical College |
| Address |
Department of Neonatology, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9838104536 |
| Fax |
|
| Email |
rahulbhakatcnmc44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Mangala Bharathi |
| Designation |
Professor and Head of Department, Department of Neonatology |
| Affiliation |
Madras Medical College |
| Address |
Department of Neonatology, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9840786836 |
| Fax |
|
| Email |
drmangalabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Mangala Bharathi |
| Designation |
Professor and Head of Department, Department of Neonatology |
| Affiliation |
Madras Medical College |
| Address |
Department of Neonatology, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9840786836 |
| Fax |
|
| Email |
drmangalabharathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology, Institute of Obstetrics and Gynaecology, Madras Medical College, Chennai |
|
|
Primary Sponsor
|
| Name |
Rahul Bhakat |
| Address |
Department of Neonatology Institute of Obstetrics and Gynaecology Madras Medical College Chennai |
| 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 S Mangalabharathi |
Institute of Obstetrics and Gynaecology |
Department of Obstetrics, Pantheon road, Egmore, Chennai, 600008
Chennai
TAMIL NADU |
9840786836
drmangalabharathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madras Medical College |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with singleton pregnancy.
2. Gestation more than or equal to 32 weeks.
3. Admission in labour ward with labour pains.
|
|
| ExclusionCriteria |
| Details |
1. Presence of antenatally detected major fetal anomaly.
2. Intrauterine death.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Agreement between the two devices in detecting Fetal heart rate.
2. Correlation coefficient between the two devices in detecting Fetal heart rate.
|
Measurement of fetal heart rate for continuous 6 minutes during first and / or second stage of labour only once at enrollment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decision taken regarding delivery of fetus |
Measurement of fetal heart rate continuously for 6 minutes during first/ second stage of labour during delivery once at the time of enrollment. |
| Detection of abnormal fetal heart rate/ Fetal distress |
Fetal heart rate will be continuously measured for 6 minutes during first/ second stage of labour during delivery once. |
| Number of device adjustments required |
During continuos measurement of fetal heart rate for 6 minutes during first/ second stage of labour. |
| Patient/ provider device satisfaction |
During continuous measurement of fetal heart rate for 6 minutes during first/ second stage of labour once. |
5. APGAR at 1 and 5 minutes
6. Degree of resuscitation required |
Neonates after delivery till resuscitation is required |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
13/04/2024 |
| 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="0"
Months="3"
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 heart rate ( FHR ) monitoring is the key parameter of intrapartum fetal monitoring and indicator of fetal hypoxia. Current non invasive FHR device technologies have challenges like - high cost of machines, requirement of dedicated space and well trained person to interpret resultant waveform and readings. This novel FHR monitoring device designed by Indian Institute of Technology Madras, extracts FHR from mother’s abdomen using photoplethysmography (PPG) method. It uses infrared technology to detect FHR, has simple robust design, is completely non invasive, safe for both mother and fetus and suitable for long term monitoring. It is easily portable, low cost, consumes less power, easy to use, requires less training or skill to operate and generates alarm if any abnormality in FHR. The availability of such novel FHR monitoring devices at peripheral facilities would help in identifying at risk fetuses for timely referral and action and also to reduce stillbirths and birth asphyxia. To compare FHR detection by novel FHR monitoring device with FHR information obtained from conventional cardiotocography.
|