| CTRI Number |
CTRI/2021/01/030572 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Mobile health platform development after child birth. |
|
Scientific Title of Study
|
Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT04693585 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Obstetrics and Gynaecology Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Obstetrics and Gynaecology Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Bagga |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Obstetrics and Gynaecology Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872494602 |
| Fax |
|
| Email |
rashmibagga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 6710 Rockledge Dr, Bethesda, MD 20817, USA |
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Bagga |
| Address |
Department of Obstetrics and Gynaecology Post Graduate Institute of Medical Education and Research Chandigarh rashmibagga@gmail.com |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dallas Swendeman Foreign CO PI |
Associate Professor-in-Residence, Department of Psychiatry & Biobehavioral Sciences, David Geffen School of Medicine at UCLA |
| Dr Alison El Ayadi Foreign PI |
Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco |
| Dr Ankita Kankaria Indian CO PI |
Dr. Ankita Kankaria Assistant Professor Department of Community and Family Medicine AIIMS Bathinda |
| Dr Nadia Griffin DiamondSmith Foreign PI |
Assistant Professor, University of California, San Francisco, Department of Epidemiology and Biostatistics, Institute for Global Health Sciences |
| Dr Vijay Kumar Indian CO PI |
Executive Director SWACH Foundation Sector 16 Near Sanatan Dharm Mandir Panchkula Haryana |
| Laura Weil Foreign CO PI |
Assistant Professor, Department of Obstetrics and Gynecology, University of California, San Francisco |
| Mona Duggal Indian PI |
Assistant Professor, Department of Advance Eye Centre Post Graduate Institute of Medical Education and Research Chandigarh India |
| Pushpendra Singh Indian COPI |
Associate Professor IIIT Delhi Okhla III New Delhi 20 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashmi Bagga |
PGIMER, Chandigarh |
Department of Obstetrics & Gynaecology
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9872494602
rashmibagga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immediate postpartum
Patients
ICD-10 Condition: Z392
Encounter for routine postpartum follow-up, |
| Patients |
(1) ICD-10 Condition: Z392||Encounter for routine postpartum follow-up, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
real-time mobile voice information and support group alone for 6 months |
| Intervention |
group 2 |
asynchronous/
on-demand text-based group support only for 6 months |
| Intervention |
group 3 |
real-time mobile voice information and support group plus asynchronous/on-demand text-based group support on 6 months |
| Comparator Agent |
group 4 |
routine postpartum care and follow up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Postnatal
2. 18+ years old,
3. postpartum period up to 2 weeks |
|
| ExclusionCriteria |
| Details |
1. women below 18 years of age
2. Women with high risk pregnancies
2. Women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Feasibility and acceptability will be assessed via back-end
data, surveys, and IDIs with purposively selected participants and moderators. |
After 6 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MCH health-related knowledge, behaviors and outcomes including exclusive breastfeeding, immunization, family planning uptake, postnatal visits, mental health and empowerment. |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/04/2021 |
| 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="6"
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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - through publications
- For how long will this data be available start date provided 31-12-2021 and end date provided 31-12-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In phase 2 we will evaluate the feasibility and acceptability of two intervention component using a controlled 4 arm factorial design (n=160, 40 per arms) 1. Real time mobile voice information and support group alone 2. Asynchronous/on demand text based support group only 3. Real time mobile voice information and support group plus asynchronous/ on demand text based support group. Feasibility and acceptability will be assessed by back end data, surveys, IDIs with 30 participants and moderators. |