| CTRI Number |
CTRI/2025/02/080478 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Smartphone Application for Point of Care Management of Anemia and Hypertension in Antenatal Mothers |
|
Scientific Title of Study
|
Smart at home screening and monitoring of Anemia and hypertension among antenatal mothers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soniya |
| Designation |
Postgraduate |
| Affiliation |
Saveetha institute of medical and technical science |
| Address |
Department of Obstetrics and Gynaecology, Saveetha institute of medical and technical science - Thandalam- kanchipuram ( 602105 ) -Tamilnadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8122265293 |
| Fax |
|
| Email |
ramsoniya22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.M.Rajalekshmi |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of obstetrics and Gynaecology, Saveetha medical college and hospital - Thandalam- kanchipuram -Tamilnadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9486668001 |
| Fax |
|
| Email |
dr.rajivijay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soniya |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology, Saveetha institute of medical and technical science- Thandalam- kanchipuram -Tamilnadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8122265293 |
| Fax |
|
| Email |
ramsoniya22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha institute of medical and technical science - Thandalam- kanchipuram district- pincode 602105- Tamilnadu- India |
|
|
Primary Sponsor
|
| Name |
Saveetha institute of medical and technical science |
| Address |
Saveetha institute of medical and technical science- Thandalam- kanchipuram district ( 602105) - Tamilnadu- India |
| 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 |
| DrSoniya |
Saveetha institute of medical and technical science |
Department of Obstetrics and Gynaecology- SIMATS , Saveetha nagar- Thandalam- kanchipuram district ( 602105), Tamilnadu
Kancheepuram
TAMIL NADU |
8122265293
ramsoniya22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Hb less than 10 gm/dl
Gestational hypertension
Chronic hypertension
Irrespective of gestational age |
|
| ExclusionCriteria |
| Details |
Ectopic pregnancy
molar pregnancy
placenta previa
Bleeding disorder
Liver disorder
Renal disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining the efficacy of Smartphone Application and non user |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the maternal & fetal morbidity & mortality among the smart phone application user & non user |
During delivery- approximate 37 weeks of gestation |
|
|
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)
|
25/02/2025 |
| 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="0"
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
|
Anemia and hypertension are common pregnancy-related conditions that can significantly impact both maternal and fetal health. Anemia, characterized by low red blood cell or hemoglobin levels, can lead to fatigue, weakness, and complications such as preterm birth or low birth weight if untreated. Hypertension, which includes gestational hypertension and preeclampsia, poses risks like organ damage and preterm birth, requiring vigilant monitoring and management. Gestational hypertension typically resolves after childbirth, while preeclampsia demands closer attention.
Effective management of these conditions through routine prenatal care is essential for preventing complications. Monitoring hemoglobin, ferritin levels, and blood pressure, alongside appropriate interventions like iron supplementation, dietary changes, and lifestyle adjustments, helps ensure better maternal and fetal outcomes. In some cases, medications may be prescribed for hypertension management.
This invention introduces a smartphone application-based point of care system designed to monitor and manage anemia and hypertension among antenatal mothers in real time. By providing healthcare providers with a platform for regular health assessments, the app enables early detection and timely interventions, reducing risks for both the mother and baby. This technology can particularly benefit underserved populations by enhancing access to care and improving prenatal health outcomes, offering a modern approach to managing these critical pregnancy conditions. |