| CTRI Number |
CTRI/2024/03/064325 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
WATCH-Bihar
(Wireless Assessment of Fetal Heart Tracing and Care for Healthy Intrapartum in Bihar
|
|
Scientific Title of Study
|
“Enhancing Intrapartum Care through Wireless Fetal Monitoring: Assessing Acceptability, feasibility, and Clinical Impact in Selected Health Facilities of Bihar†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MONIKA ANANT |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS PATNA |
| Address |
Room 242 C, Department of Obstetrics & Gynaecology
OPD building
AIIMS PATNA AIIMS Patna Phulwarisharif, Patna Patna BIHAR 801507 India |
| Phone |
7764946249 |
| Fax |
|
| Email |
drmonika.anant@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MONIKA ANANT |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS PATNA |
| Address |
Room 242 C, Department of Obstetrics & Gynaecology
OPD building
AIIMS PATNA
Phulwarisharif
Patna Patna BIHAR 801507 India |
| Phone |
7764946249 |
| Fax |
|
| Email |
drmonika.anant@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
MONIKA ANANT |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS PATNA |
| Address |
Room 242 C, Department of Obstetrics & Gynaecology
OPD building
AIIMS PATNA Phulwarisharif
Patna Patna BIHAR 801507 India |
| Phone |
7764946249 |
| Fax |
|
| Email |
drmonika.anant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bill and Melinda Gates Foundation |
|
|
Primary Sponsor
|
| Name |
bill and melinda gates foundation |
| Address |
BMGF, Washigton DC ,United states OF America |
| Type of Sponsor |
Contract research organization |
|
|
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 Monika Anant |
All India Institute of Medical Sciences Patna |
Labour room, IPD B1A, Department of Obstetrics & Gynaecology
AIIMS Patna, Phulawarisharif, near WALMI Patna BIHAR |
7764946249
drmonika.anant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fetal monitoring device |
Fetal monitoring device will be applied to women in labour at study sites.
The fetal monitoring will continue for duration of labour 6-8 hours |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Consenting singleton pregnant women in labour (first stage) 18-40 years |
|
| ExclusionCriteria |
| Details |
1) Multiple pregnancy
2) Malpresentations
3) Previously scarred uterus (cesarean section, myomectomy)
4) Pregnant Women requiring referral for other high-risk conditions like eclampsia,sepsis, severe anemia, heart disease
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Feasibility of using such devices in healthcare settings of Bihar.
The qualitative part: to assess the perceptions and experiences of laboring women towards the use of wireless fetal monitoring devices will be available analyzed thematically using qualitative content analysis.
The most important outcome will be on the detection of fetal distress in time to get
intervention and improved stillbirth rates. |
6 months, 12 months and 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the clinical utility of wireless fetal monitoring devices by comparing the proportion of abnormal fetal heart rate tracings captured to actual incidence of fetal asphyxia in babies requiring emergency delivery, resuscitation or neonatal care |
6 months, 12 months, 18 months |
|
|
Target Sample Size
|
Total Sample Size="9720" Sample Size from India="9720"
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)
|
01/04/2024 |
| 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="1" Months="6" 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
|
:Enhancing Intrapartum Care through Wireless Fetal Monitoring: Assessing Acceptability, feasibility, and Clinical Impact in
Selected Health Facilities of Bihar Objective 1: To assess the clinical utility of wireless fetal monitoring (WFM) devices by comparing the proportion of abnormal fetal heart rate (FHR)tracings captured to the actual incidence of fetal asphyxia in babies requiring emergency delivery, resuscitation, or NICU care.
Objective 2: To evaluate the feasibility, usability, and learnability of wireless fetal monitoring devices when utilized by frontline healthcare workers during intrapartum care.
Objective 3: To explore the perceptions and experiences of laboring women towards the use of wireless fetal monitoring device. Study design - Prospective observational study
Study site- 3 centers-Arwal District Hospital, FRU Phulwarisharif, SDH Danapur
Population- 9720 antenatal women
Intervention (if any)- Intrapartum wireless electronic fetal monitoring
Comparison Group (if any) - No
Outcome Measures -This objective aims to determine the effectiveness of WFM in early detection of fetal distress and its potential impact on improving perinatal outcomes
Sample size estimation (if required)-9720 antenatal women
Statistical analysis- descriptive analysis
Ethical issues- All data analysis will be conducted in compliance with
ethical guidelines to ensure participant confidentiality and privacy. Feasibility of using such devices in healthcare settings of Bihar will be better and whether the healthcare workers are able to use it for the benefit of labouring women.
The qualitative part of the study is to assess the perceptions and experiences of laboring women towards the use of wireless fetal monitoring devices will be available analyzed thematically using qualitative content analysis
The most important outcome will be on the detection of fetal distress in time to get intervention and improved stillbirth rates.
|