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CTRI Number  CTRI/2024/06/069391 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 23/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A observational study regarding outcomes in mothers and newborn babies when pregnant women have complaints of reduced baby movements during her pregnancy. 
Scientific Title of Study   Maternal and fetal outcomes in pregnant women with reduced fetal movements-A observational study. 
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. Jana harshitha sree chandana 
Designation  MS post graduate 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  Department of Obstetrics and Gyneacology, Jawaharlal Nehru medical college, Nehru nagar, Belagavi KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  8074507074  
Fax    
Email  jana.chandana26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mrityunjay Chandrashekar Metgud 
Designation  Professor and Guide 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  Department of Obstetrics and Gynaecology, KAHERs Jawaharlal Nehru Medical College, Nehru nagar, Belagavi- 590010 KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Mrityunjay Chandrashekar Metgud 
Designation  Professor and Guide 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  Department of Obstetrics and Gynaecology, KAHERs Jawaharlal Nehru Medical college, Nehru nagar, Belagavi-590010

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm@rediffmail.com  
 
Source of Monetary or Material Support  
KAHERs Dr.Prabhakar kore hospital and medical research center, nehru nagar belagavi - karnataka - 590010 08312473777 
 
Primary Sponsor  
Name  Dr Jana Harshitha Sree Chandana  
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi- 590010 BELGAUM KARNATAKA 
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 Jana Harshitha Sree Chandana  KAHERs Dr. Prabhakar kore Hospital and Medical Research Centre, Belgavi  Department of Obstetrics and Gynaecology, Lobour room, Jawaharlal Nehru Medical College, Nehru Nager,Belagavi-590010,BELGAUM KARNATAKA
Belgaum
KARNATAKA 		 8074507074

jana.chandana26@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: O268||Other specified pregnancy relatedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All the pregnant women at or beyond 28 weeks period of gestation with singleton pregnancy admitted in labour room with complaints of reduced fetal movements  
 
ExclusionCriteria 
Details  Pregnant women with fetus having already known congenital anomalies or having multifetal pregnancy or diagnosed intrauterine fetal death or pregnant women less than 28 weeks period of gestation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess maternal and fetal outcomes in pregnant women who comes with complaints of reduced fetal movements  During pregnancy, at delivery and post partum 
 
Secondary Outcome  
Outcome  TimePoints 
To assess risk factors in pregnant women who comes with complaints of reduced fetal movements  During pregnancy, at delivery and post partum 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   08/07/2024 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    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 - Proposals should be directed to [jana.chandana26@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Daily fetal movement counting is a simple practice which provides a valuable insight into the health of the fetus , making it easy and accessible method of monitoring fetal well being on a daily basis , normally a healthy fetus is indicated by the presence of 10 - 12 movements per day, which can be defined as any discrete kick , flutter, swish or roll . This practice will help physicians to take timely interventions and helps for improving good perinatal outcomes. Fetus will respond to reduced utero placental blood flow and fetal hypoxia leading to decreased fetal movements and it is associated with adverse outcomes like low APGAR  score, preterm births , stillbirths , fetal anomalies , and risk of deaths and others , and decreased fetal movements is also can be associated with many high risk maternal factors like preeclampsia , abruptio placenta, amniotic fluid disorders, placenta previa and others. 
Need of this study is to asses the fetomaternal outcomes and understand associated risk factors in this part of country around belgavi region, as it is important to identify high risk pregnant women and take timely, appropriate interventions that will also help in improving the well being of both mother and the child.
 
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