| CTRI Number |
CTRI/2025/08/093595 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Phd NURSING thesis ] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of AnshCare App on maternal and neonatal outcomes among mothers and their newborns. |
|
Scientific Title of Study
|
A cluster randomized control trial to assess the effectiveness of AnshCare App on maternal and neonatal outcomes among mothers and their newborn registered at antenatal clinics of Haryana. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANPREET KAUR |
| Designation |
PhD Schlolar |
| Affiliation |
Maharishi Markandeshwar College of Nursing, Mullana, Ambala. |
| Address |
Dept Obsterics and Gynaecological Nursing, Maharishi Markandeshwar College of Nursing,
Maharishi Markandeshwar (Deemed to be University),
Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA
133207
India |
| Phone |
7015111594 |
| Fax |
|
| Email |
manpreet.kalka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VINAY KUMARI |
| Designation |
VICE PRINCIPAL CUM PROFESSOR |
| Affiliation |
Maharishi Markandeshwar College of Nursing, Mullana, Ambala |
| Address |
Dept of Medical Surgical Nursing, Vice principál Office, Ground floor, Maharishi Markandeshwar College of Nursing,
Maharishi Markandeshwar (Deemed to be University),
Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA
133207
India |
| Phone |
7973596469 |
| Fax |
|
| Email |
viceprincipalmmcn@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
DRVINAY KUMARI |
| Designation |
VICE PRINCIPAL CUM PROFESSOR |
| Affiliation |
Maharishi Markandeshwar College of Nursing, Mullana, Ambala |
| Address |
Dept of Obstetric and Gynaecological Nursing, Maharishi Markandeshwar College of Nursing,
Maharishi Markandeshwar (Deemed to be University),
Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA
133207
India |
| Phone |
7973596469 |
| Fax |
|
| Email |
viceprincipalmmcn@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Deemed to be university Mullana Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala |
| Address |
Maharishi Markandeshwar College of Nursing,
Maharishi Markandeshwar (Deemed to be University),
Mullana, Ambala, haryana 133207 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Vinay Kumari |
M.M Deemed to be University Mullana Ambala |
Dept Of Osbtetric and gyanecology, MMIMSR, Maharishi Markandeshwar Deemed to be University Mullana, Ambala Haryana 133207
Ambala
HARYANA |
7973596469
viceprincipalmmcn@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ANTENATAL MOTHERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANSHCARE APP |
ANSHCARE app is an educational supportive app for antenatal mothers that will help them to develop self-management habits and take care of themselves at their homes. The AnshCare app comprised of advises on diet, Rest & sleep, antenatal visits, Investigations required during pregnancy, Precautions and warning signs of pregnancy, Medications and supplementations, Treatment of minor ailments of pregnancy, Demonstration on antenatal & postnatal exercises, Preparation for childbirth, Breast feeding and care of newborn. |
| Comparator Agent |
ROUTINE CARE |
Routine/conventional care for antenatal mothers given by obstetrician attending OPD at Antenatal Clinics |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal Mothers able to Read hindi or English, use mobile app, having android mobile phone/ability to install app
|
|
| ExclusionCriteria |
| Details |
antenatal mothers able to:
Unwilling to install the app
Twin pregnancy
High risk pregnancy (as defined by consulting gynaecologist)
Had any psychiatric comorbidity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maternal outcome: it includes trimester wise outcomes of pregnancy after 2nd and 3rd trimester which includes weight gain, BPA and Blood Sugar, Hb, Urinary Protein, TT Coverage, Maintaining Fetal movement count, any abortion, Antepartum Haemorrhage, Maternal near miss, Term or preterm delivery, NVD or LSCS, Emergency LSCS, On time admission to hospital, Initiation of breastfeeding, Maternal emotional and psychological well-being, Postnatal follow up.
Neonatal Outcome: it includes immediate newborn parameters includes Gestational age, Birth Weight, NICU Admission,Neonatal Death, Any congenital malformation.
|
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2026 |
| 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 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
|
Mobile health refers to use of mobile phones app for antenatal mothers to provide instructions, demonstrations and health education regarding care during pregnancy, to support and provide health and healthcare services.
Most studies reported the feasibility and positive user acceptance of m health by pregnant mothers because it provides many benefits in providing equitable health services. However, the m health apps will not replace the medical professionals in actual settings, but it’s not doubt that these apps will be a great tool for medical staff, family members and patients by playing an important role to maintain healthy lifestyle and prevention of complications. So in future it will be required to establish collaboration between gynecologists, Nursing staff and IT experts to form apps and their direction of use.
Today, with the substantial progression of medical technologies in the field of pregnancy and childbirth, the world of applications and websites has entered all aspects of human life, including pregnancy. These days, it can be hardly seen a pregnant woman who is unacquainted of health status of her fetus. Therefore, the group of motherhood has been and is a very worthwhile and popular subject for launching startups in the world, so that if we look at virtual stores, we can encounter with a considerable variety of apps and websites in the field of motherhood. this study aimed to develop a App for antenatal mothers and to assess the effectiveness of the app on maternal and neonatal outcomes. |