| CTRI Number |
CTRI/2026/03/105411 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Empowered Decision making on Maternal Autonomy , Satisfaction and Neonatal Wellbeing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see whether decision-making support during labor helps mothers make their own choices, improves their satisfaction and newborn wellbeing at IMS and SUM Hospital, Bhubaneswar |
|
Scientific Title of Study
|
A study to assess the effect of empowered decision making during intrapartum care on maternal autonomy satisfaction and neonatal wellbeing among antenatal mothers at IMS and SUM Hospital of Bhubaneswar Odisha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pearl Sett |
| Designation |
MSc. Nursing |
| Affiliation |
SUM NURSING COLLEGE |
| Address |
SUM Nursing College Department Of Obstetrics and Gynaecological Nursing Siksha o Anusandhan University Kalinganagar Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7044145600 |
| Fax |
|
| Email |
pearlsett@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Debajani Nayak |
| Designation |
Associate Professor |
| Affiliation |
SUM NURSING COLLEGE |
| Address |
SUM Nursing College Department Of Obstetrics and Gynaecological Nursing Siksha o Anusandhan University Kalinganagar Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8895656977 |
| Fax |
|
| Email |
debjaninayak@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pearl Sett |
| Designation |
MSc. Nursing |
| Affiliation |
SUM NURSING COLLEGE |
| Address |
SUM Nursing College Department Of Obstetrics and Gynaecological Nursing Siksha o Anusandhan University Kalinganagar Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7044145600 |
| Fax |
|
| Email |
pearlsett@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM Hospital Siksha o Anusandhan Deemed to be University Kalinganagar Bhubaneswar Odisha India Pin 751003 |
|
|
Primary Sponsor
|
| Name |
PEARL SETT |
| Address |
SUM Nursing College Department Of Obstetrics and Gynaecological Nursing Siksha o Anusandhan University Kalinganagar Bhubaneswar |
| 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 |
| Pearl Sett |
IMS AND SUM HOSPITAL |
Department of Obstetrics and Gynaecological Nursing
Labour Room Obstetrics Unit
IMS & SUM Hospital
Siksha O Anusandhan University
Kalinga Nagar
Bhubaneswar
Odisha 751003
India
Khordha
ORISSA |
7044145600
pearlsett@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant antenatal Mother |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Empowered Decision Making Intervention |
The intervention consisted of providing empowered decision making support during intrapartum care This included educating mothers about available options encouraging them to participate actively in decisions regarding their labor and delivery process and ensuring respectful maternity care practices No drugs devices or invasive procedures were used as part of the intervention The intervention will be delivered in three stages An antenatal education session at 36 40 weeks of pregnancy lasting approximately 20 minutes reinforcement at admission during early labor lasting about 10 minutes and a post test assessment 24 48 hours after delivery lasting approximately 15 minutes |
| Comparator Agent |
Routine standard antenatal and intrapartum care |
Participants in the control group will receive routine standard antenatal and intrapartum care as per hospital protocol This includes regular antenatal checkups routine counselling monitoring during labor standard nursing and obstetric management and usual postnatal care No structured empowered decision making education sessions or reinforcement will be provided to this group Participants in the control group will receive routine standard antenatal and intrapartum care as per the hospital protocol at IMS and SUM Hospital Bhubaneswar This includes routine antenatal checkups standard counselling monitoring of maternal and fetal condition routine nursing and obstetric management during labor and delivery and usual postnatal care No structured empowered decision making education or reinforcement sessions will be provided to the control group Each routine antenatal consultation generally lasts approximately 10 15 minutes depending on the clinical condition of the mother |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged 18 35 years
Women at term gestation 36 40 weeks
Women who are willing to participate
Able to communicate and provide informed consent
Women who will attend the antenatal clinic in IMS and SUM Hospital and will deliver the baby in IMS and SUM Hospital. |
|
| ExclusionCriteria |
| Details |
High-risk pregnancies such as preeclampsia gestational diabetes placenta previa
Intrauterine fetal demise or known fetal anomalies
Women requiring emergency obstetric intervention upon admission
Inability to understand the language used for counseling and communication
Women who are unable to attend three intervention
Mothers who are psychologically unstable |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Empowered decision making during intrapartum care improves maternal autonomy satisfaction and neonatal well being |
Empowered decision making during intrapartum care maternal autonomy satisfaction and neonatal well being will be assessed 24 to 48 hours after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
02/04/2026 |
| 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="1"
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
|
This randomized controlled trial aims to assess the effect of empowered decision making during intrapartum care on maternal autonomy, maternal satisfaction, and neonatal wellbeing among antenatal mothers at IMS and SUM Hospital, Bhubaneswar, Odisha. A total of 106 eligible pregnant women aged 18 to 35 years will be selected and randomly allocated into experimental and control groups using lottery method simple randomization. The experimental group will receive empowered decision making support during intrapartum care, including information sharing, encouragement of participation in care decisions, and respectful maternity practices. The control group will receive routine standard intrapartum care. Maternal autonomy and maternal satisfaction will be assessed using structured questionnaires after delivery, and neonatal wellbeing will be assessed using Apgar scores. The study aims to evaluate whether empowered decision making improves maternal experience and neonatal outcomes. |