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CTRI Number  CTRI/2020/03/024289 [Registered on: 26/03/2020] Trial Registered Prospectively
Last Modified On: 18/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health Education intervention]  
Study Design  Other 
Public Title of Study   Mobile based Appliction on "Pregnancy Care" 
Scientific Title of Study   Develop and Evaluate the effectiveness of Mobile Application on “Pregnancy Care” in terms of Awareness, Expressed practices and Anxiety among Primigravida Mothers attending Antenatal OPD of Selected Hospitals of Northern India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manpriya Kaur 
Designation  Research scholar 
Affiliation  Maharishi Markandeshwar deemed to be university 
Address  MM College of Nursing, Mullana Ambala Haryana 133207 India

Ambala
HARYANA
133207
India 
Phone  8054437496  
Fax    
Email  manpriya.grewal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam Sheoran 
Designation  Professor 
Affiliation  Maharishi Markandeshwar deemed to be university 
Address  MM College of Nursing, Mullana Ambala Haryana 133207 India

Ambala
HARYANA
133207
India 
Phone  8059930267  
Fax    
Email  poonamsheoran@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Manpriya Kaur 
Designation  Research scholar 
Affiliation  Maharishi Markandeshwar deemed to be university 
Address  MM College of Nursing, Mullana Ambala Haryana 133207 India

Ambala
HARYANA
133207
India 
Phone  8054437496  
Fax    
Email  manpriya.grewal@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Medical Sciences and Research.  
 
Primary Sponsor  
Name  Maharishi Markandeshwar deemed to be University 
Address  Mullana, Ambala Distt, Haryana, 133207 
Type of Sponsor  Private medical college 
 
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 
Manpriya Kaur  Antenatal OPD of selected hospitals of Northern India  MMDU,Mullana,Ambala distt, Haryana, 133207, Ambala, Haryana
Ambala
HARYANA 		 8054437496

manpriya.grewal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primigravida mothers attending first antenatal visit 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mobile application based antenatal education  Mobile application on "Pregnancy Care" used by the primigravida mothers will be prepared in local language that includes health education components such as antenatal check-up,minor ailments in pregnancy, diet in pregnancy, birthing process and breastfeeding. This package will be delivered in an excluded room which is located near OPD without any other individual being present. Utilization and acceptability of the Mobile App will be assessed through google analytics and telephonic survey.  
Comparator Agent  Routine antenatal care  Routine antenatal care as given in the study hospital 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primigravida mothers:
1. willing to participate in the study and give informed consent.
2. attending antenatal OPD and who will be available during the data collection period
3.can speak and read Hindi/English
4.having android mobile phone.
5.Daily user of smart phone.

 
 
ExclusionCriteria 
Details  Primigravida mothers :-
1.having any visual/hearing /mental disability.
2.having miscarriage during recruitment process.
3.with pregnancy complication.
4.who develop any complication during the period of study will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in awareness among Primigravida mothers regarding pregnancy care.
2. Improvement in expressed practices regarding pregnancy care by Primigravida mothers.
3. Prevalence of pregnancy specific anxiety. 		 at time of recruitment,at 20 wks, at 26 wks, at 30 wks, at 34 wks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Ease of availability of health information on pregnancy care through Android based application.
2.Increase in satisfaction and reduce number of hospital visits for minor ailments. 		 at time of recruitment,at 20 wks, at 26 wks, at 30 wks, at 34 wks 
 
Target Sample Size   Total Sample Size="540"
Sample Size from India="540" 
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)   01/08/2020 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   App based approach is one of the strategy to educate the primigravida mothers on different aspects of antenatal care such as antenatal advices, exercises, about diet in pregnancy, minor ailments of pregnancy, birthing process and breastfeeding. If the application is provided in their local language then it will be easy for the antenatal mother to understand various aspects of antenatal care.
Currently the number of women accessing the complete antenatal care package (to monitor the fetal development and to know about maternal well-being) is quite low which results in delay in reaching the health facility and ultimately increases the risk of complications to both mother and baby. To fulfil the needs of the pregnant mothers, credible applications related to pregnancy, birth and child care should be developed in local language and managed by qualified health professionals, so that there will be quick provision of credible professional information for the pregnant mothers. Policy experts should consider merging m-health programs in the national health agendas to achieve SDG goals and targets and reduce maternal and newborn mortality and morbidity rates. In India, m-Health is still in seedling stage and hence more studies are required to prove its role in delivering maternal and new born health care.

STATEMENT OF THE PROBLEM

A study to develop and evaluate the effectiveness of Mobile Application on “Pregnancy Care” in terms of awareness, expressed practices and pregnancy specific anxiety among primigravida mothers attending antenatal OPD of selected hospitals of Northern India.

OBJECTIVES OF THE STUDY

The study will be conducted based on following objectives-

1.      To develop and validate the Mobile Application on “Pregnancy Care”

2.      To assess and compare the post-test scores of awareness regarding antenatal care among primigravida mothers in experimental and comparison group.

3.      To assess and compare the post-test scores of expressed practices regarding antenatal care among primigravida mothers in experimental and comparison group.

4.      To assess and compare the post-test scores of pregnancy specific anxiety among primigravida mothers in experimental and comparison group

5.      To determine the correlation between awareness, expressed practices and pregnancy specific anxiety among primigravida mothers.

6.      To find the association of awareness and expressed practices with the selected socio-demographic variables.

7.      To ascertain the accessibility and usability of the Mobile Application on “Pregnancy Care” by the primigravida mothers.

8.      To determine the opinion of primigravida mothers on acceptability of the Mobile Application on “Pregnancy Care”. 
 
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