| CTRI Number |
CTRI/2025/06/089593 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to improve the pregnancy outcome using moblie technology |
|
Scientific Title of Study
|
Improving antenatal care with mhealth A randomized controlled trial in northeast 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 |
Lothunglo Ezung |
| Designation |
Junior resident |
| Affiliation |
AIIMS, Guwahati |
| Address |
Department of Obstetrics and Gynaecology, Ground floor, AIIMS Guwahati, Changsari, Assam
Kamrup
ASSAM
781101
India |
| Phone |
7005773408 |
| Fax |
|
| Email |
ezunglolo15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr HIMANGSHU MALAKAR |
| Designation |
associate professor |
| Affiliation |
AIIMS, Guwahati |
| Address |
Department of Obstetrics and Gynaecology, Ground floor, AIIMS Guwahati, Changsari, Assam
Kamrup
ASSAM
781101
India |
| Phone |
9854609022 |
| Fax |
|
| Email |
himangshumalakar@aiimsguwahti.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Lothunglo Ezung |
| Designation |
Junior resident |
| Affiliation |
AIIMS, Guwahati |
| Address |
Department of Obstetrics and Gynaecology, Ground floor, AIIMS Guwahati, Changsari, Assam
ASSAM
781101
India |
| Phone |
7005773408 |
| Fax |
|
| Email |
ezunglolo15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lothunglo Ezung |
| Address |
Department of Obstetrics and Gynaecology, Ground floor, AIIMS Guwahati, Changsari, Assam. |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lothunglo Ezung |
AIIMS Guwahati |
Department of Obstetrics and Gynaecology, Ground floor, AIIMS Guwahati, Changsari, Assam.
Kamrup
ASSAM |
7005773408
ezunglolo15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Committee, AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
STANDARD ANTENATAL CARE |
Comparing antenatal outcomes between antenatal women using the swasthgarbh app with antenatal care versus patients receiving only standard care. Edit || Delete
|
| Comparator Agent |
Swasthgarbh app |
Comparing antenatal outcomes between antenatal women using the swasthgarbh app with antenatal care versus patients receiving only standard care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1IMPROVED ANTENATAL CARE COMPLIANCE -BETTER ADHERENCE TI ANTENATAL CHECKUPTESTS AND SUPPLEMENTS
2IMPROVED HAEMOGLOBIN LEVEL
3EARLIER DETECTION OF PREGNANCY COMPLICATIONS
4TO ASSESS COMPLIANCE TO TIMELY SUPPLEMENY=TS INTAKE AND LABORATORY INVESTIGATIONS
|
|
| ExclusionCriteria |
| Details |
Women with comorbidities like chronic diseases. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improved antenatal care compliance - better adherence to antenatal checkup, tests and supplements.
2. Improved hemoglobin level.
3. Earlier detection of pregnancy complications.
4. To assess compliance to timely supplement intake and laboratory investigations. |
Participants will be recruited from the first six months of study period till the target sample size is reached and they will be followed up till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improved maternal knowledge and awareness after app usage.
2. Better pregnancy experience and improved patient satisfaction. |
Participants will be recruited from the first six months of study period till the target sample size is reached and they will be followed up till delivery |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
08/07/2025 |
| 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
|
This randomized controlled trial evaluates the impact of the SwasthGarbh mobile application on antenatal care among pregnant women in Northeast India. Conducted at AIIMS Guwahati, the study includes 190 participants, randomly divided into intervention and control groups. Women in the intervention group received standard antenatal care along with access to the SwasthGarbh app, while the control group received only standard care. The app provides features like appointment reminders, educational content, symptom tracking, and guidance on investigations and supplement intake. The study aims to improve maternal hemoglobin levels, antenatal visit compliance, and reduce obstetric and medical complications. It also seeks to enhance maternal knowledge and satisfaction with care. Participants will be recruited from the first trimester and followed out the through delivery. The study targets the underserved tribal population, aiming to bridge the digital health gap and promote evidence-based maternal care. Findings are expected to support the wider use of mHealth tools to strengthen maternal health services in low-resource settings. |