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CTRI Number  CTRI/2022/12/048438 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 14/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Phone based app]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Development of a mobile App, SwasthGarbh, for improving care of women during pregnancy 
Scientific Title of Study   Development and Validation of phone-based App, SwasthGarbh, for improving antenatal care (ameliorating maternal and fetal health)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Sharma 
Designation  Assistant professor 
Affiliation  Indian Institute of Technology, Roorkee 
Address  Department of Biotechnology, IIT Roorkee, Civil lines, uttarakhand, india , roorkee, Uttarakhand-247667
Department of Biotechnology, IIT Roorkee, Civil lines, uttarakhand, india , roorkee, Uttarakhand-247667
Hardwar
UTTARANCHAL
247667
India 
Phone  958270027  
Fax    
Email  deepak.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak Sharma 
Designation  Assistant professor 
Affiliation  IIT, Roorkee 
Address  Department of Biotechnology, IIT Roorkee, Civil lines, uttarakhand, india , roorkee, Uttarakhand-247667
Department of Biotechnology, IIT Roorkee, Civil lines, uttarakhand, india , roorkee, Uttarakhand-247667
Hardwar
UTTARANCHAL
247667
India 
Phone  958270027  
Fax    
Email  deepak.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepak Sharma 
Designation  Assistant professor 
Affiliation  IIT Roorkee 
Address  Department of Biotechnology, IIT Roorkee, Civil lines, uttarakhand, india , roorkee, Uttarakhand-247667
Department of Biotechnology, IIT Roorkee, Civil lines, uttarakhand, india , roorkee, Uttarakhand-247667
Hardwar
UTTARANCHAL
247667
India 
Phone  958270027  
Fax    
Email  deepak.aiims@gmail.com  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  ICMR 
Address  Indian council of medical research, Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vatsla Dadhwal  AIIMS, New Delhi  Third floor, Teaching blockDepartment of Obstetrics and Gynaecology, Ansari Nagar, New Delhi 110029
South
DELHI 		 9811015979

vatslad@hotmail.com 
Dr Anupama Bahadur  AIIMS, Rishikesk  Department of Obstetrics and Gynaecology, AIIMS, Rishikesh, Virbhadra Road, Rishikesh Uttarakhand- 249 203, India
Dehradun
UTTARANCHAL 		 9810326959

anupama.bahadur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
Institute Ethics Committee, AIIMS, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Patients followed up for routine antenatal care not registered under the app  Women not registered on the App will be treated as the control group. Patients will be monitored till their full-term or delivery as routine antenatal care  
Intervention  Use for SwasthGarbh app for antenatal follow up  The doctors will be provided smartphones. Pregnant women will be registered on the App upto 16 weeks of their LMP dates. All the registrations and data entries during ANC visits will be done by the doctor to ensure the veracity of the data. Furthermore, to prevent unauthorized sending of notifications to any patient, a security feature has been incorporated in the App so that notifications can be sent to a patient only after the first login.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Pregnant women, age between 18-40 years
2. Period of gestation upto 16 weeks
3. Women giving consent 
 
ExclusionCriteria 
Details  1. Multiple pregnancy
2. Women with chronic medical disorders
3. Women not attending ANC at AIIMS 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Adherence to antenatal visits and increase in total number of AN visits.
2.Adherence to iron/folate supplementation as evidenced by hemoglobin levels of women.

 		 patients will be recruited before 16 week and followed in pregnancy at 28 week, 32 week and 37 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Compare the number of contact pregnant woman made with health care provider for any health problem, beyond regular antenatal visits.
2.Maternal response to ease of use and usefulness of the App.
3. Decrease in Obstetric and Medical complications in pregnant women.
 		 patients will be recruited before 16 week and followed in pregnancy at 28 week, 32 week and 37 week 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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   Phase 2 
Date of First Enrollment (India)   01/01/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
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

  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.richavatsa@gmail.com].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2031?
    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  

Antenatal care (ANC) is must for preventing complications during pregnancy and to ensure healthy mother/child. We will develop a multi-functional smartphone application ‘SwasthGarbh’ (Healthy Pregnancy) for the assistance of pregnant women regarding all the ANC visits and to keep a record of every clinical test/parameter as well as get reminders for the next/missed ANC visit or medication. It will provide a detailed graphic visualization of the systolic/diastolic BP and weight for an easy overview of all the data. Most importantly, both the woman and doctor will get automatic notification if any parameter(s) crosses normal range or any danger sign is present so that timely medical assistance can be provided. Women will have the freedom to inform the doctor about any problem/symptom she is facing on an SOS basis. On getting this information along with clinical reports (if any), the doctor will be able to advise as well as prescribe medicines in real-time (through notification/call). Moreover, the embedded feature, ANC Assist, will help doctors to automatically calculate the schedule of all ANC visits of any patient. Furthermore, to provide assistance in case of any emergency, the App will also display a map highlighting all the nearby hospitals that can be reached in a short time. In addition, it would be possible to install the App in any language desired by the user. Both patients as well as doctors will be able to avail the benefits of the App free of cost!

After the development of App, it will be installed in smartphones provided to primary health care workers and doctors to conduct a clinical study for demonstrating the utility of the App (towards improvement in Hb levels, increase in number of antenatal visits and decrease in obstetric/medical complications). SwasthGarbh will be of immense help for maintaining maternal/fetal health as well as for preventing complications during pregnancy (especially for millions of pregnant women who are living in rural areas and/or do not have easy access to doctors). It aims to provide real-time medical assistance in case of any emergency. It will be an interactive platform which will significantly promote prenatal care in every part of the world. This will be the first pregnancy App that will provide instantaneous access to doctor’s advice and is clinically endorsed as well as credible.

 
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