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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  
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 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  
Status 
Not Applicable 
 
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
 
 
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.
 
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