| CTRI Number |
CTRI/2023/11/059806 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Obstetric Quality of recovery following Elective and Emergency Cesarean Delivery in Southern Indian population using OBsQoR-11 scoring system. |
|
Scientific Title of Study
|
To evaluate and test reliability, clinical acceptability and feasibility of obstetric quality of recovery score OBsQoR-11 scoring for assessing postoperative recovery after cesarean delivery. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEENAKSHI T |
| Designation |
Pg student anesthesia |
| Affiliation |
vydehi institute of medical sciences and research centreehi inst |
| Address |
Vydehi institute of medical sciences and research centre, Anesthesia Department, Bangalore
Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
8073744059 |
| Fax |
|
| Email |
mnksh97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sathyanarayan J |
| Designation |
Associate professor |
| Affiliation |
Kauvery Hospital , Marthahalli |
| Address |
Department of Anesthesia, Kauvery Hospital, old airport road, Marthahalli Bangalore
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
7204222070 |
| Fax |
|
| Email |
sathyaforall2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sathyanarayan J |
| Designation |
Associate proffessor |
| Affiliation |
Kauvery Hospital , Marthahalli |
| Address |
Department of Anesthesia, Kauvery Hospital, old airport road, Marthahalli Bangalore
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
7204222070 |
| Fax |
|
| Email |
sathyaforall2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
vydehi institute of medical sciences and research centre |
| Address |
vydehi institute of medical sciences and research centre, Nallurhalli Main Road, Whitefield, Bangalore |
| 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 Meenakshi T |
vydehi institue of medical sciences and research centre |
Anesthesia Department, 1st floor, operation theatre complex, Bangalore, Karnataka
Bangalore
KARNATAKA |
8073744059
mnksh97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VYDEHI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O748||Other complications of anesthesiaduring labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients undergoing Elective or emergency LSCS,
2)ASA 1-2
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal for the study
2)Inability to read, listen and understand the questionnaire
3)patients who have severe pre-existing medical conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the OBsQoR-11 following non-elective and elective cesarean delivery by testing validity, reliability, clinical acceptability and feasibility |
24 hours postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional recovery and Readiness for Discharge on Postop day 1 |
24 hours postpartum till the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
20/11/2023 |
| 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="0"
Months="2"
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
|
cesarean delivery id one of the most common performed surgical procedures globally. The quality of recovery after cesarean delivery is mostly assessed using single dimensional outcomes like visual analogue scale, morbidity or mortality rate . However, recovery after cesarean delivery depends on many factors, such as patient, surgical procedures and anesthetic factors and postoperative complications. OBsQoR-11 scale which is derived from the QoR-40 scale to assess the quality of recovery in first hours after cesarean delivery. This score is a 11 item questionnaire which has very good correlation with measures of recovery like global health status and lenght of hospital stay. |