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CTRI Number  CTRI/2024/06/068692 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 08/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Emergency obstetric referral patterns to a Tertiary care centre: A cross-sectional observational study in North Karnataka, India 
Scientific Title of Study   Emergency obstetric referral patterns to a Tertiary care centre: A cross-sectional observational study in North Karnataka, India 
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 Pankti Parikh 
Designation  MS Postgraduate 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynaecology, JNMC Campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7045663643  
Fax    
Email  panktipparikh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hema S Patil 
Designation  Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynaecology, JNMC Campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9164342888  
Fax    
Email  hemabanad@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Hema S Patil 
Designation  Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynaecology, JNMC Campus, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9164342888  
Fax    
Email  hemabanad@yahoo.com  
 
Source of Monetary or Material Support  
KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi 590010 
 
Primary Sponsor  
Name  Dr Pankti Parikh 
Address  Department of Obstetrics and Gynaecology, JNMC Campus, Nehru Nagar, Belagavi 590010 
Type of Sponsor  Other [Self] 
 
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 Pankti Parikh  KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre  Department of Obstetrics and Gynaecology, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA 		 7045663643

panktipparikh1001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All antepartum, intrapartum and postpartum women referred to the labor room, emergency department, ICU of the hospital will be included in the study. Self referrals will also be included in the study. 
 
ExclusionCriteria 
Details  All registered obstetric cases delivered in KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify the patterns of emergency obstetric referrals to a tertiary hospital. Analysis of this data will help strengthen the primary and secondary health centres and hence reduce maternal and neonatal mortality  Antepartum, Intrapartum and Postpartum women referred to the hospital 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the maternal and perinatal outcomes of the referred cases  At the time of delivery and postpartum 
 
Target Sample Size   Total Sample Size="185"
Sample Size from India="185" 
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)   20/06/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included panktipparikh1001@gmail.com).

  6. For how long will this data be available start date provided 02-08-2026 and end date provided 02-12-2064?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study aims to identify the common indications for referrals, so as to strengthen skill training of the health workers in peripheral health centres and hence prevent the last minute referrals to reduce morbidity and mortality. The data will help formulate better policies for efficient and timely referrals to tertiary care centres. This will help to come up with appropriate interventions to improve obstetric outcomes in the district of Belagavi 
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