| CTRI Number |
CTRI/2026/03/106113 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Helping Pregnant Women With Anaemia Take Their Iron tablets regularly to improve health condition: A Support Program Study” |
|
Scientific Title of Study
|
Effectiveness of an Intervention on Improving Medication Adherence in Pregnant Women with Anaemia: A Single-Blind Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mridula Murali Manohar |
| Designation |
MBBS Student |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
Department of Pharmacology,
PG Room 1st floor,
Medical College Block,
SRM Medical College Hospital And Research Centre
Chennai
TAMIL NADU
603203
India |
| Phone |
09597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jerin James |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
Department of Pharmacology,
1st floor room no 6,
Medical College Block,
SRM Medical College Hospital And Research Centre
Chennai
TAMIL NADU
603203
India |
| Phone |
09597908321 |
| Fax |
|
| Email |
jerinjames06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridula Murali Manohar |
| Designation |
MBBS Student |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
Department of Pharmacology,
1st floor PG Room,
Medical College Block,
SRM Medical College Hospital And Research Centre
Chennai
TAMIL NADU
603203
India |
| Phone |
09597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology,
Ground floor hospital block,
SRM Medical College Hospital and Research Centre,Chengalpattu district 603203,TamilNadu,India |
|
|
Primary Sponsor
|
| Name |
SRM Institute Of Science And Technology |
| Address |
SRM Medical College Hospital And Research Centre,
Potheri, Kattankulathur,
Chengalpattu district 603203,
TamilNadu, India. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Mridula Murali Manohar |
SRM Medical College Hospital and Research Centre |
Obstetrics And Gynaecology Department, Ground floor, Hospital Block.
Chennai
TAMIL NADU |
9597908321
ss4838@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Education And Behavioural Support |
Pregnant women with anaemia receiving structured educational counselling and behavioural support like reminders once a week to improve medication adherence along with standard antenatal care.
|
| Comparator Agent |
Routine Antenatal Care |
Pregnant women with anaemia receiving routine standard of care without any educational support or any behavioural support like reminders to improve medication adherence |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between 13 and 24 gestational weeks,
Age between 20 and 40 years
Hemoglobin level at recruitment of 7.0 to 10.9 g/dL
Recent onset as well as already on medication
Who could read and write in Tamil or English, and had access to a smartphone with
WhatsApp
|
|
| ExclusionCriteria |
| Details |
Pregnant women were excluded if they had underlying diseases such as hemoglobinopathy(thalassemia, hemoglobin E), Chronic Diseases(cancer, chronic renal disease)or infectious disease (HIV, Malaria)
Symptoms of anemmia (shortness of breath, chest pain, syncope) in current pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The expected results include insights into the level of drug adherence among pregnant women with anemia factors influencing adherence or non-adherence, and the extent of awareness regarding medication adherence.
2.The improvement in medication adherence after the intervention will also be assessed These findings could guide interventions to improve medication adherence, reduce healthcare costs, and enhance patient-specific care strategies.
|
9 months |
|
|
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)
|
30/03/2026 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 single-blind randomized controlled trial evaluated the effectiveness of a combined educational and behavioural intervention on medication adherence among 98 pregnant women with moderate anaemia (Hb 7.0–10.9 g/dL) at 24–32 weeks of gestation. Participants were randomized into an intervention group receiving structured counselling on anaemia and iron therapy along with daily WhatsApp reminders, or a control group receiving routine iron therapy alone. The primary outcome was change in medication adherence measured using the MMAS-8 scale. The intervention group showed a significant improvement in adherence scores (5.18 ± 0.8 to 7.91 ± 0.6; p<0.001), compared to modest improvement in the control group (5.08 ± 0.7 to 7.01 ± 0.6; p<0.05). Post-intervention adherence was significantly higher in the intervention group. Although hemoglobin levels improved more in the intervention group, the difference between groups was not statistically significant. The findings suggest that combining structured education with digital behavioural reminders effectively enhances adherence to iron supplementation during pregnancy. Integrating such low-cost and scalable interventions into routine antenatal care may improve maternal health outcomes. |