| CTRI Number |
CTRI/2023/11/059750 [Registered on: 10/11/2023] Trial Registered Prospectively |
| Last Modified On: |
27/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Adverse events following cesarean delivery in mother and child |
|
Scientific Title of Study
|
Anaesthesia related maternal and fetal adverse events after cesarean delivery a prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Azhaguparvathi a |
| Designation |
Postgraduate student |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Room no 5 ground floor new ot complex
Vims Contonment ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9345589871 |
| Fax |
|
| Email |
azhaguab97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha h |
| Designation |
Assistant professor |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Room no 5 ground floor new ot complex anaesthesiology department vims ballari
Room no 5 ground floor new ot complex vims ballari
Bellary
KARNATAKA
583104
India |
| Phone |
8095106846 |
| Fax |
|
| Email |
hanuradha19@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha h |
| Designation |
Assistant professor |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Room no 5 ground floor new ot complex anaesthesiology department vims ballari
Room no 5 ground floor new ot complex vims ballari
Bellary
KARNATAKA
583104
India |
| Phone |
8095106846 |
| Fax |
|
| Email |
hanuradha19@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar institute of medical sciences Contonment ballari |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences Contonment ballari |
| Address |
Room no 5 ground floor new ot complex anaesthesiology department vims ballari |
| 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 Azhaguparvathi a |
Vijayanagar institute of medical sciences |
Room no 5 ground floor new ot complex vims Contonment ballari
Bellary
KARNATAKA |
9345589871
azhaguab97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BALLARI. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients more than 18 years
2.Patient who is having term pregnancy (37 week) undergoing cesarean delivery in department of VIMS , ballari due to various maternal and fetal indications.
3.Patients who categorized as ASA physical status class 2 and above
4.All booked and non-booked patient
5.Patients who are willing to participate will be included in this study after an informed and written consent |
|
| ExclusionCriteria |
| Details |
1.Patients who refuse to participate in this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of peri operative anaesthesia related maternal adverse events in patients undergoing cesarean delivery. |
From intra operative period to 24 hours postoperatively after cesarean delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the type of anaesthesia related adverse events including hypoxia, desaturation, hypotension, hypocarbia, pain, hypothermia, post operative nausea & vomiting, need for o2 supplementation, any other form of ventilatory support
2)Assess for correlation with types of anaesthetic drugs, obstetric history, medical history and co-morbidities.
3)To assess the incidence of anaesthesia related neonatal adverse outcomes in terms of APGAR score at 1 min and 5 mins, umblical cord blood gas analysis, NICU admission
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
10/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/11/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Here we are going to observe the rate of anaesthesia related maternal complications and newborn
outcome related to cesarean deliveries. On arrival to the operating room, basal
vital parameters (Heart rate, Blood pressure, Respiratory rate, ECG) will be
recorded. Cesarean delivery will be performed under neuraxial or general anaesthesia.
The choice of anaesthesia method is determined based on medical history,
obstetric history, co-morbidities and contraindications.
Patients will receive standard anaesthesia
as per institutional protocol. The mode of anaesthesia, dose and the drug used
in anaesthesia will be recorded. The adverse events are
hypoxia, desaturation, hypotension, hypocarbia, pain, hypothermia, post
operative nausea and vomiting, need for o2 supplementation, any other form of
ventilator support, APGAR score at 1 min and 5 min, umbilical cord blood gas
analysis, NICU admission will be assessed. |