| CTRI Number |
CTRI/2024/06/069403 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
It is a study to compare airway parameters changes following vaginal delivery and caesarean section under spinal anaesthesia among parturients |
|
Scientific Title of Study
|
Comparison of airway parameters changes in parturients following caesarean section and vaginal 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 |
Dr Renu Bala |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Modular OT complex second floor, Pt. B.D. Sharma PGIMS Rohtak.
Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8901322251 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Panwar |
| Designation |
Junior resident |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak. |
| Address |
Department of Anaesthesiology and critical care, Modular OT complex second floor, Pt. B.D. Sharma PGIMS Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9872681490 |
| Fax |
|
| Email |
Ankupanwar21@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Panwar |
| Designation |
Junior resident |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak. |
| Address |
Department of Anaesthesiology and critical care, Modular OT complex second floor, Pt. B.D. Sharma PGIMS Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9872681490 |
| Fax |
|
| Email |
ankupanwar21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak ,Haryana , India
PIN code 124001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and critical care PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care, Modular OT complex second floor, Pt. B.D. Sharma PGIMS Rohtak. |
| Type of Sponsor |
Government 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 Ankita Panwar |
Pt B.D Sharma PGIMS ROHTAK |
Department of Anaesthesiology and critical care, Modular OT second floor, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA |
9872681490
ankupanwar21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt. B.D. Sharma PGIMS Rohtak |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
A total of 120 parturients in the age group 18-40 years , belonging to ASA II admitted for elective caesarean section under spinal anaesthesia or vaginal delivery will be enrolled. |
|
| ExclusionCriteria |
| Details |
Refusal for consent, twin pregnancy , hypertensive disorders, pre-eclampsia, eclampsia, diabetes , obesity, difficult airway due to oral, cervical spine , neck pathology, grade 4MMPG, general, anaesthesia administration for caesarean section or other complications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Airway parameters(MMPG) following vaginal delivery and caesarean section will be assessed. |
Before delivery
One hour after delivery
6 hours after delivery
24 hours after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of airway parametres (TMD, THMDR, Sternomental distance, hyomental distance, upper lip bite test, inter incisor distance, neck circumference, chest circumference, tongue width & thickness)following vaginal delivery |
Before delivery
One hour after delivery
Six hours after delivery
24 hours after delivery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/07/2024 |
| 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="3"
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
|
Airway related complications contribute to most common causes of maternal mortality and morbidity. It occurs due to various anatomical and physiological factors. The pre-dominant factor responsible for aggravating airway oedema is the pushing and straining during labour. Pharyngeal oedema due to fluid retention , antidiuretic properties of oxytocin , decrease of oncotic pressure due to fluid administration , increased return of blood by uterine contraction results in increase in MMPG after Caesarean delivery. The present study is an observational study which is proposed to clinically assess airway indices in parturients undergoing cesarean section under spinal anaesthesia and compare it with those undergoing normal vaginal delivery. |