| CTRI Number |
CTRI/2023/12/060428 [Registered on: 01/12/2023] Trial Registered Prospectively |
| Last Modified On: |
11/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of recovery from caesarean section in pregnant patients. |
|
Scientific Title of Study
|
Evaluation of recovery from caesarean section using Obstetric Quality of Recovery-10 (ObsQoR-10) as patient reported outcome measure: An Observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Chhabra |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
D and T OT complex Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07340033034 |
| Fax |
|
| Email |
swati_virgo83@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Chhabra |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
D and T OT complex Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07340033034 |
| Fax |
|
| Email |
swati_virgo83@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
T TEJASWI VASUDEVA RAO |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
D and T OT complex Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08008004822 |
| Fax |
|
| Email |
vasudevomc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Basni phase 2 Jodhpur 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Jodhpur 342005 |
| 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 |
| Dr Swati Chhabra |
All India Institue of Medical Sciences Jodhpur |
D and T OT complex Department of Anaesthesiology and Critical Care
Jodhpur
RAJASTHAN |
07340033034
swati_virgo83@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS, JODHPUR |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant patients undergoing Caesarean section (elective and emergency)
|
|
| ExclusionCriteria |
| Details |
Patients denying consent to participate in the study.
Patient on mechanical ventilation postoperatively.
Patients leaving against medical advice before 24 hours postoperative period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of ObsQoR-10 score in patients undergoing elective and emergent caesarean section.
|
24 hours and Day 30 postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of recovery of patients undergoing caesarean section using Obstetric Quality of Recovery-10 (ObsQoR-10) tool as patient reported outcome measure.
To assess the length of hospital stay
To assess the readmission within 30 days after caesarean section
To evaluate bundle compliance to individual ERAC interventions
To assess the barrier to implementation of individual ERAC interventions
|
Intraoperative, 24 hours post surgery and day 30 |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/12/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study will be a prospective observational study conducted over a period of 18 months. Pregnant patients undergoing caesarean section, both elective and emergency cases, will be included in the study. The ObsQoR-10 questionnaire will be administered to patients 24 hours post-surgery. Length of hospital stay, occurrence of complications such as PONV and pruritus, and readmission within 30 days will also be recorded. Data analysis will involve comparing continuous variables using analysis of variance or nonparametric tests, and associations among discrete and categorical variables will be analyzed using chi-square or Fisher exact tests.
|