| CTRI Number |
CTRI/2026/02/103495 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Cafeteria approach in Labour Analgesia - Acceptance and Effectiveness among parturients |
|
Scientific Title of Study
|
Cafeteria Approach in Obstetric Analgesia: Acceptance and Effectiveness of Parturient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandhana V |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBGYN
Women and Child Block
Kasturba Hospital, Eshwar Nagar, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
6383406458 |
| Fax |
|
| Email |
v.nandhana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBGYN
Women and Child Block
Kasturba Hospital, Eshwar Nagar, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nandhana V |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBGYN
Women and Child Block
Kasturba Hospital, Eshwar Nagar, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
6383406458 |
| Fax |
|
| Email |
v.nandhana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Department of OBGYN
Kasturba Medical college, Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 NANDHANA |
Kasturba Hospital |
Department of OBGYN, Kasturba Hospital, Eshwar Nagar, Manipal, Udupi
Udupi
KARNATAKA |
6383406458
v.nandhana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Cephalic presentation
Term pregnancy more than 37weeks
Women in active labour – Cervical dilatation more than 4cm
Spontaneous or Induced labour |
|
| ExclusionCriteria |
| Details |
Contraindications to any of the three analgesic options
Known h/o opioid allergy
High risk pregnancies (Eg-Pre-eclampsia, thrombocytopenia)
Multiple pregnancies
Refusal to participate
Non-reassuring NST or fetal distress |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maternal Pain relief effectiveness |
From active labour and at 30mins, 1 hour and 2 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Acceptance of each analgesic method
Duration of labour |
24hours postpartum |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/02/2026 |
| 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)
|
Open to Recruitment |
| 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 is a prospective observationalstudy : 90 participants are expected to participate in this study. This study will take place at the Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal. We will recruit participants (parturient in labor) will be counseled about the different pain relief options available under the cafeteria approach— the risks and benefits associated with each option i.e. Tramadol vs Entonox vs epidural analgesia. They will be free to choose the method of analgesia that best suits their preference and comfort. The chosen intervention will then be administered according to the proposed standard protocol and under proper supervision. During and after labor, data will be collected as per the proforma regarding pain relief, satisfaction levels, acceptance of the chosen method, and overall effectiveness in improving the childbirth experience
|