| CTRI Number |
CTRI/2026/03/105268 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
31/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [quasi experimental ] |
| Study Design |
Other |
|
Public Title of Study
|
Online and In Person Childbirth Education to Help First Time Mothers Prepare for Delivery and Have Healthier Births |
|
Scientific Title of Study
|
Effectiveness of Hybrid Birth Sensitisation Programme to enhance Preparedness for Labour and its impact in Primigravida of Multiple Hospitals in Thiruvanathapuram, Kerala |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SYAMA L S |
| Designation |
PHD SCHOLAR |
| Affiliation |
COLLEGE OF NURSING SCIENCES, DAYANANDA SAGAR UNIVERSITY, BANGALORE |
| Address |
DEPARTMENT OF OBSTETRICAL AND GYNAECOLOGICAL NURSING COLLEGE OF NURSING SCIENCES UNDER SCHOOL OF HEALTH SCIENCES DAYANANDA SAGAR UNIVERSITY HAROHALLI CAMPUS BANGALORE
Bangalore
KARNATAKA
562112
India |
| Phone |
9539743424 |
| Fax |
|
| Email |
jyothi08my@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAMUNA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
COLLEGE OF NURSING SCIENCES, DAYANANDA SAGAR UNIVERSITY, BANGALORE |
| Address |
DEPARTMENT OF OBSTETRICAL AND GYNAECOLOGICAL NURSING COLLEGE OF NURSING SCIENCES UNDER SCHOOL OF HEALTH SCIENCES DAYANANDA SAGAR UNIVERSITY HAROHALLI CAMPUS BANGALORE
Bangalore
KARNATAKA
562112
India |
| Phone |
9901600987 |
| Fax |
|
| Email |
drjamuna-nsg@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
KARTHIKA R |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
LITTLE FLOWER COLLEGE OF NURSING THIRUVNANTHAPURAM |
| Address |
DEPARTMENT OF CHILD HEALTH NURSING LITTLE FLOWER COLLEGE OF NURSING UNDER JUBILEE MEMORIAL HOSPITAL MONVILA THIRUVAVANATHAPURAM
Thiruvananthapuram
KERALA
695583
India |
| Phone |
9495758695 |
| Fax |
|
| Email |
karthikar5565@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUT Pattom
Multi Super Specialty Hospital Pattom Palace Road Pattom PO Thiruvananthapuram Kerala 695004 India |
|
|
Primary Sponsor
|
| Name |
SYAMA L S |
| Address |
ROADARIKATHU VEEDU, ARUVIKKARA, KOOVALLASSERY P O |
| 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 |
| Bindhu Krishna |
SUT HOSPITAL |
Department of Obstetrical and Gyanecological Nursing Antenatal and Postnatal Units SUT Pattom
Multi Super Specialty Hospital Pattom Palace Road Pattom PO Thiruvananthapuram Kerala 695004 India
Thiruvananthapuram
KERALA |
9995154401
quality.dept@sutpattom.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN SUBJECT RESEARCH SREE UTHRADAM THIRUNAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HYBRID BIRTH SENSITISATION PROGRAMME |
Module 1 Pregnancy Process Education
Physiology of pregnancy
Fetal development
Pregnancy complications and warning signs
Module 2 Positive Pregnancy Interventions incorporating the principles of haptonomy
I Physical Preparation
II Mental preparation
Module 3 Preparedness for Childbirth
Physical preparedness
Mental preparedness
Lactation preparedness
Module 4 Talking Therapy for Thought Pattern Change through individual and group discussions
Identifying negative thought patterns
Challenging and reframing negative thoughts
Building self confidence and selfesteem
E CONTENT
The e content will be shared among experimental group including reading modules PPT educational videos exercise demonstration videos, testimonials and FAQS via Google Classroom and individual monitoring will be done through WhatsApp
|
| Comparator Agent |
PRIMIGRAVIDA MOTHER |
PRIMIGRAVIDA MOTHERS ATTENDING ANTENATAL CLINICS |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida mothers
Mothers in the age group of 19 to 30 years
Primigravida in singleton pregnancy
Mothers in the second trimester completed 20 weeks of gestation
Mothers who do not have communication issues
Mothers who have access to digital platforms
|
|
| ExclusionCriteria |
| Details |
Not willing to participate in the study
High-risk antenatal mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| KNOWLEDGE LEVEL OF PREPAREDNESS IN LABOUR |
At 20weeks 28weeks 34weeks and post delivery within 1week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MATERNAL AND NEONATAL CHILDBIRTH OUTCOMES |
WITHIN 1 WEEK AFTER DELIVERY |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/03/2026 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study aims to assess the baseline knowledge on preparedness of labour among primigravida mothers to evaluate the effectiveness of a Hybrid Birth Sensitisation Programme in improving the knowledge on preparedness of labour and maternal and child birth outcomes among primigravida mothers and also to examine the association between pre-test birth preparedness knowledge scores and selected socio-demographic variables This study seeks a quasi-experimental approach to assess the knowledge on birth preparedness and its impact in childbirth outcomes among primigravida mothers by evaluating the effectiveness of the Hybrid Birth Sensitization Programme The study also explores the possibilities of digital platforms in improving health care quality among pregnant women and hence creates a positive pregnancy and childbirth experience. |